michelesleepscoring.comCerebra Sleep System
Cerebra Medical Ltd.
CEREBRA MEDICAL
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008517706 | 3008517706 | CEREBRA MEDICAL | 1 | N | 2020-04-25 | 1470 Willson Place Unit B Winnipeg Manitoba CA R3T 3N9 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B6005537160 | MICHELE SLEEP SCORING SYSTEM - The MICHELE Sleep Scoring System is a Computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients. | 18779493202 | info@michelesleepscoring.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 119821 | 1931858014 | K112102 | MICHELE SLEEP SCORING SYSTEMS | MNR | 2011-12-20 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MNR | 1 | 2011-12-20 |
PMN#
GUDID#
MICHELE SLEEP SCORING SYSTEM - The MICHELE Sleep Scoring System is a Computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. The MICHELE Sleep Scoring System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients.
2018-02-12
Cerebra Sleep System - The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. The system uses polysomnography (PSG) to record the electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effort, pulse rate, and oxyhemoglobin saturation, depending on the sleep study configuration. The Cerebra Sleep System is for prescription use in a home or healthcare facility. The Cerebra Sleep System is intended to be used as a support tool by physicians and PSG technologists to aid in the evaluation and diagnosis of sleep disorders. It is intended to provide sleep-related information that is interpreted by a qualified physician to render findings and/or diagnosis, but it does not directly generate a diagnosis.
2022-07-13