| Primary Device ID | B6005537160 |
| NIH Device Record Key | 9670deea-4578-4e2c-9ccc-0064d249cd14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MICHELE SLEEP SCORING SYSTEM |
| Version Model Number | 1 |
| 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 | true |
| 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 | B6005537160 [Primary] |
| MNR | Ventilatory Effort Recorder |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2018-02-12 |
| 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 | 2019-12-11The 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. |
| 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 |