| Primary Device ID | B600700014 |
| NIH Device Record Key | 6e0af953-5b7d-438b-badf-b95828ffa1d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cerebra Sleep System |
| Version Model Number | 700014 |
| Company DUNS | 203513726 |
| Company Name | Cerebra Medical Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B600700014 [Primary] |
| OMC | Reduced- Montage Standard Electroencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-21 |
| Device Publish Date | 2022-07-13 |
| B600700014 - Cerebra Sleep System | 2022-07-21The 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. |
| B600700014 - Cerebra Sleep System | 2022-07-21 The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological sig |
| B6005537160 - MICHELE SLEEP SCORING SYSTEM | 2019-12-11 The MICHELE Sleep Scoring System is a Computer program (software) intended for use as an aid for the diagnosis of sleep and resp |