The following data is part of a premarket notification filed by Dawn Medical with the FDA for Somniprobe Ii Nasal And Buccal Airflow Mon. Syst..
| Device ID | K904118 |
| 510k Number | K904118 |
| Device Name: | SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST. |
| Classification | Spirometer, Diagnostic |
| Applicant | DAWN MEDICAL 210 SAN BENITO WAY San Francisco, CA 94127 |
| Contact | Bruce Fitzgerald |
| Correspondent | Bruce Fitzgerald DAWN MEDICAL 210 SAN BENITO WAY San Francisco, CA 94127 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-06 |
| Decision Date | 1991-02-25 |