The following data is part of a premarket notification filed by Salter Labs, Division Of Regulatory Affairs with the FDA for Salter Labs Oral/nasal Thermal Airflow Sensor.
| Device ID | K080922 |
| 510k Number | K080922 |
| Device Name: | SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR |
| Classification | Monitor, Breathing Frequency |
| Applicant | SALTER LABS, DIVISION OF REGULATORY AFFAIRS 100 WEST SYCAMORE RD. Arvin, CA 93203 |
| Contact | Duane Kazal |
| Correspondent | Duane Kazal SALTER LABS, DIVISION OF REGULATORY AFFAIRS 100 WEST SYCAMORE RD. Arvin, CA 93203 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-01 |
| Decision Date | 2008-07-25 |
| Summary: | summary |