The following data is part of a premarket notification filed by Salter Labs with the FDA for Pneumotherml, Model: 5800.
| Device ID | K092685 |
| 510k Number | K092685 |
| Device Name: | PNEUMOTHERML, MODEL: 5800 |
| Classification | Monitor, Breathing Frequency |
| Applicant | SALTER LABS 100 W. SYCAMORE RD. Arvin, CA 93203 |
| Contact | Terry Newton |
| Correspondent | Terry Newton SALTER LABS 100 W. SYCAMORE RD. Arvin, CA 93203 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-02 |
| Decision Date | 2009-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607411889745 | K092685 | 000 |
| 00607411006906 | K092685 | 000 |
| 00607411006890 | K092685 | 000 |
| 00607411006883 | K092685 | 000 |
| 10607411006873 | K092685 | 000 |