The following data is part of a premarket notification filed by Salter Labs with the FDA for Salter Labs 8990 Series Nebulizer.
| Device ID | K962085 |
| 510k Number | K962085 |
| Device Name: | SALTER LABS 8990 SERIES NEBULIZER |
| 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 | 1996-05-29 |
| Decision Date | 1996-08-26 |
| Summary: | summary |