The following data is part of a premarket notification filed by Salter Labs with the FDA for Hand Held Nebulizer System.
| Device ID | K884947 |
| 510k Number | K884947 |
| Device Name: | HAND HELD NEBULIZER SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
| Contact | James N Curti |
| Correspondent | James N Curti SALTER LABS P.O. BOX 608 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 | 1988-11-25 |
| Decision Date | 1989-02-17 |