البلد: سنغافورة
اللغة: الإنجليزية
المصدر: HSA (Health Sciences Authority)
Mandarin Opto-Medic Co Pte Ltd
Class B medical device
Diagnosys LLC
Ophthalmology
Ophthalmic electrophysiology systems intended for detection or assessment of diseases and eye conditions (eg neurological or ophthalmological disease, unexplained visual loss, paediatric neurology, opacities in media, monitoring health-toxicity, detection of the disease or carrier states of inherited visual disorders, quantitative assessment of visual disease and assessment of retinal and optic nerve function following trauma.)”
Device System Info:[Device with measuring function], System functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). The waveforms are then interpreted.; Models: D310 Ophthalmic Electrophysiology System Platform - D310-B-2-27F-N-N, D310 Ophthalmic Electrophysiology System Platform - D310-B-2-27F-N-T, D310 Ophthalmic Electrophysiology System Platform - D310-B-2-27F-N-X, D310 Ophthalmic Electrophysiology System Platform - D310-B-2-27F-N-B, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-27F-2-T, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-27F-2-X, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-27F-2-B, D310 Ophthalmic Electrophysiology System Platform - D310-N-4-27F-2-B, D310 Ophthalmic Electrophysiology System Platform - D310-N-4-27F-2-T, D310 Ophthalmic Electrophysiology System Platform - D310-N-4-27F-2-X, D310 Ophthalmic Electrophysiology System Platform - D310-N-4-27F-N-B, D310 Ophthalmic Electrophysiology System Platform - D310-N-4-27F-N-N, D310 Ophthalmic Electrophysiology System Platform - D310-N-4-27F-N-T, D310 Ophthalmic Electrophysiology System Platform - D310-N-4-27F-N-X, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDXS-N-N, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDXR-N-N, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDNS-N-N, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDNR-N-N, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDXS-2-N, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDXR-2-N, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDNS-2-N, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDNR-2-N, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDXS-N-T, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDXR-N-T, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDNS-N-T, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDNR-N-T, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDXS-N-X, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDXR-N-X, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDNS-N-X, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDNR-N-X, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDXS-2-T, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDXR-2-T, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDNS-2-T, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDNR-2-T, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDXS-2-X, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDXR-2-X, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDNS-2-X, D310 Ophthalmic Electrophysiology System Platform - D310-R-2-CDNR-2-X, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDXS-N-N, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDXR-N-N, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDNS-N-N, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDNR-N-N, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDXS-2-N, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDXR-2-N, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDNS-2-N, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDNR-2-N, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDXS-N-T, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDXR-N-T, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDNS-N-T, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDNR-N-T, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDXS-N-X, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDXR-N-X, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDNS-N-X, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDNR-N-X, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDXS-2-T, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDXR-2-T, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDNS-2-T, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDNR-2-T, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDXS-2-X, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDXR-2-X, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDNS-2-X, D310 Ophthalmic Electrophysiology System Platform - D310-G-2-CDNR-2-X, Espion Ophthalmic Electrophysiology System, Profile - D310, 5-Channel 32-Bit Isolated Medical Amplifier - D300, ColorDome - D125, ColorBurst - D213, LCD Monitor - D358, Envoy OLED Monitor with stand - D352, D343 - D343, Full-field Scotopic Threshold (FST) - D196, Pupillometry module - D355, Ganzfeld/ Pattern Control Unit - D301, Ganzfeld Control Unit - D302, Pattern Control Unit - D303, Power Unit - D305, Cart - D356, DTL Plus Electrode - D141, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDNSL-NN-N-N-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-NNNNN-27-N-N-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-NNNNN-NN-2-N-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-NNNNN-NN-N-T-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-NNNNN-NN-2-T-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-NNNNN-27-N-T-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDNRL-NN-N-N-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDXSL-NN-N-N-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDXRL-NN-N-N-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDNSL-27-N-N-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDNRL-27-N-N-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDXSL-27-N-N-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDXRL-27-N-N-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDNSL-27-2-T-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDNRL-27-2-T-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDXSL-27-2-T-P, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDNSL-NN-N-N-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-NNNNN-27-N-N-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-NNNNN-NN-2-N-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-NNNNN-NN-N-T-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-NNNNN-NN-2-T-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-NNNNN-27-N-T-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDNRL-NN-N-N-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDXSL-NN-N-N-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDXRL-NN-N-N-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDNSL-27-N-N-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDNRL-27-N-N-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDXSL-27-N-N-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDXRL-27-N-N-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDNSL-27-2-T-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDNRL-27-2-T-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDXSL-27-2-T-D, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDXRL-27-2-T-D, LCD Benchtop Assembly w/Monitor and fixation camera - D359, Desktop Ganzfeld Stand - D164, Espion Ophthalmic Electrophysiology System, E3 - D315, D315 Espion E3 Electrophysiology System Console - D315-1-2-CDXRL-27-2-T-P
2018-11-02