The following data is part of a premarket notification filed by Salter Labs with the FDA for Salter Aire Compressor.
Device ID | K992285 |
510k Number | K992285 |
Device Name: | SALTER AIRE COMPRESSOR |
Classification | Nebulizer (direct Patient Interface) |
Applicant | SALTER LABS 100 W. SYCAMORE RD. Arvin, CA 93203 |
Contact | Duane Kazal |
Correspondent | Duane Kazal SALTER LABS 100 W. 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 | 1999-07-07 |
Decision Date | 2000-01-07 |
Summary: | summary |