País: Singapur
Idioma: inglés
Fuente: HSA (Health Sciences Authority)
HEARLIFE PTE. LTD.
Class B medical device
Diagnostic Group LLC - DBA Grason-Stadler
Ear, Nose & Throat
Can be used as part of an audiometric test battery. It can be used to assess the status of cochlear function. It can be used to enable estimation of behavioral hearing threshold by evoking auditory brainstem response (ABR) or steady state brainstem response (SSEP). It can be used to aid in the detection of lesions in the auditory pathway. It can be applied to neonates, infants, children and adults
Device System Info:[Device with measuring function], [System or Procedure Pack], Device with Measuring Function System or Procedure Pack; Models: GSI Audera OAE Probe/Pod with Test Cavity - 2001-4000, test cavity 2001-7010, Insert Earphones with 9’ cable - 1700-9624, GSI Audera Loop-back cable - 2001-9608, Electrodes, 6mm cup, 12 pk - 8000-0282, Electrodes, 10mm cup, 12 pk - 8000-0274, Electrode Linker - 8000-0270, Disposable side snap electrodes, 25 pk - 8500-0060, Electrode Leads, Snap, 5 pk - 019-419000, NuPrep Gel, 4 oz. tube - 016-402500, Ten 20 Paste, 4 oz. tube - 016-402200, Infant eartips, 3.5mm, 20 pk - 1700-9621, Infant eartips, 4.0mm, 20pk - 1700-9631, 3A foam eartips, 10mm, 100pk - 1700-9604, 3A foam eartips, 13mm, 100pk - 1700-9605, Eartip Kit, Infant - 2002-9662, Eartip Kit, Child/Adult - 2002-9663, Eartip Kit, Adult - 2002-9664, Audera - 8020272, Audera - 8020273, Audera - 8020274, Audera - 8020275, Audera - 8020276, Audera - 8020277, Audera - 8020278
2012-09-04