The following data is part of a premarket notification filed by Cerebra Medical Ltd. with the FDA for Cerebra Sleep System.
| Device ID | K213007 |
| 510k Number | K213007 |
| Device Name: | Cerebra Sleep System |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | Cerebra Medical Ltd. 1470 Wilson Place Unit B Winnipeg, CA R3T2N9 |
| Contact | Sharon Cholowsky |
| Correspondent | Mary Vater Medical Device Academy Inc. 345 Lincoln Hill Road Shrewsbury, VT 05738 |
| Product Code | OLV |
| Subsequent Product Code | OLZ |
| Subsequent Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2022-07-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B600700014 | K213007 | 000 |