The following data is part of a premarket notification filed by Salter Labs with the FDA for Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984).
| Device ID | K961476 |
| 510k Number | K961476 |
| Device Name: | SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | SALTER LABS 100 WEST SYCAMORE RD. Arvin, CA 93203 |
| Contact | James N Curti |
| Correspondent | James N Curti SALTER LABS 100 WEST SYCAMORE RD. Arvin, CA 93203 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-18 |
| Decision Date | 1996-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607411918360 | K961476 | 000 |
| 00607411004995 | K961476 | 000 |
| 00607411006937 | K961476 | 000 |
| 10607411890427 | K961476 | 000 |
| 10607411890434 | K961476 | 000 |
| 10607411890441 | K961476 | 000 |
| 10607411890465 | K961476 | 000 |
| 10607411890472 | K961476 | 000 |
| 10607411890502 | K961476 | 000 |
| 10607411890526 | K961476 | 000 |
| 10607411891837 | K961476 | 000 |
| 10607411891851 | K961476 | 000 |
| 10607411917735 | K961476 | 000 |
| 10607411918084 | K961476 | 000 |
| 10607411976237 | K961476 | 000 |