The following data is part of a premarket notification filed by Salter Labs with the FDA for Bi-naps Nasal Airflow And Snore Transducer.
| Device ID | K051313 |
| 510k Number | K051313 |
| Device Name: | BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER |
| Classification | Ventilatory Effort Recorder |
| Applicant | SALTER LABS 100 W. SYCAMORE RD. Arvin, CA 93203 |
| Contact | Duane Kazal |
| Correspondent | Duane Kazal SALTER LABS 100 W. SYCAMORE RD. Arvin, CA 93203 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-19 |
| Decision Date | 2005-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607411920124 | K051313 | 000 |