Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 45753 - automated lensmeter - the application is intended to retrieve the optical parameters of eyeglasses.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 33843 - sleep assessment device - the device is intended to record patient data such as patient respiratory airflow, snoring, blood oxygen saturation, pulse, respiratory effort, body position, eeg, eog, ecg, emg and wrist movement during sleep. it can also be connected to a cpap/auto cpap/bpap system through the pressure monitoring port of the mask to record and display continuous positive airway pressure. the device uses these recordings to produce report that may aid in the screening or diagnosis of sleep disordered breathing for further clinical investigation. the device is intended for the hospital / institutional environment (supervised) and the home environment (unsupervised) use for adults.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 57812 - radiology dicom image processing application software - the devices are intended to assist radiologists in the triaging or prioritization of radiological images with suspected findings.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 32568 - stereotactic surgery system, neurological - alpha omega neurosmart system is intended to be used in assisting neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons to aid in the placement of depth electrodes.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 32568 - stereotactic surgery system, neurological - the neuro omega system including the drive headstage unit, is intended to assist neurosurgeons in the operating room during functional neurosurgery and to record from and stimulate brain motor and sensory neurons and to aid in the placement of depth electrodes. it is also intended to: - monitor, record and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor, record and display the electrical activity produced by nerves to aid the clinician in the diagnosis and prognosis of neuromuscular disease (emg). -measure, record and display the electrical activity of the patient's brain obtained from two or more electrodes on the patient?s head (eeg). -measure, record, and display the electrical activity of the patient's brain obtained from ecog strip and grid electrodes. -provide stimulation via electrode pairs or a hand-held bipolar probe for use in functional brain mapping procedures during treatment of patients with seizure disorder. the device is intended for intraoperative use by medical personnel in hospitals, laboratory, clinic or nursing home settings or outside of a medical facility under direct supervision of a medical professional. the device may also be placed in the intensive care unit or operating room for continuous recording.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 47143 - electrosurgical diathermy system cable, single-use - the electrode input cable is intended to connect the electrode to the headstage drive unit.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 44835 - sterilant, hydrogen peroxide - the sterilant cassette products are designed to be used with a low temperature plasma sterilization system. they are intended to be inserted in the sterilizer chamber to proceed the sterilization process.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 44245 - stationary panoramic/tomographic dental x-ray system, digital - this system is a digital extra oral source x-ray system intended to take panoramic and cephalometric images of the oral and maxillofacial anatomy to provide diagnostic information for adult and pediatric patients.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 44606 - hand-held intraoral dental x-ray system, digital - this device is an extra oral source of x-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures.

Austrália - angličtina - Department of Health (Therapeutic Goods Administration)

emergo asia pacific pty ltd t/a emergo australia - 57813 - cpap/bipap face mask, single-use - the masks channel airflow from ventilator systems non-invasively to patients who suffer from obstructive sleep apnea (osa) or respiratory insufficiency and respiratory failure. the masks are to be used by adult patients (greater than 30 kg) requiring non-life-support ventilator assistance. the masks are intended for single-patient use, for a maximum of seven days, in the hospital or clinical environment.