The following data is part of a De Novo classification by Cereve, Inc. with the FDA for Cereve Sleep System.
| DeNovo ID | DEN140032 |
| Device Name: | Cereve Sleep System |
| Classification | Thermal System For Insomnia |
| Applicant | CEREVE, INC. 333 Allegheny Ave., 2nd Floor North Oakmont, PA 15139 |
| Contact | Eric Nofzinger |
| Product Code | PLU |
| CFR Regulation Number | 882.5700 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Direct |
| Date Received | 2014-10-20 |
| Decision Date | 2016-05-13 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |