The following data is part of a premarket notification filed by Somnitec, Inc. with the FDA for Somniprobe(r) Model Number 10093, Modification.
| Device ID | K912234 |
| 510k Number | K912234 |
| Device Name: | SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION |
| Classification | Spirometer, Diagnostic |
| Applicant | SOMNITEC, INC. 7732 BURNET AVE. Van Nuys, CA 91405 |
| Contact | Mark S London |
| Correspondent | Mark S London SOMNITEC, INC. 7732 BURNET AVE. Van Nuys, CA 91405 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-17 |
| Decision Date | 1991-07-22 |