The following data is part of a premarket notification filed by Somnitec, Inc. with the FDA for Somnimic (r).
| Device ID | K912817 |
| 510k Number | K912817 |
| Device Name: | SOMNIMIC (R) |
| Classification | Device, Sleep Assessment |
| Applicant | SOMNITEC, INC. C/O DAWN MEDICAL 210 SAN BENITO WAY San Francisco, CA 94127 |
| Contact | Bruce Fitzgerald |
| Correspondent | Bruce Fitzgerald SOMNITEC, INC. C/O DAWN MEDICAL 210 SAN BENITO WAY San Francisco, CA 94127 |
| Product Code | LEL |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-21 |
| Decision Date | 1991-07-26 |