The following data is part of a premarket notification filed by Airlife, Inc. with the FDA for Misty Nebulizer.
Device ID | K802477 |
510k Number | K802477 |
Device Name: | MISTY NEBULIZER |
Classification | Nebulizer (direct Patient Interface) |
Applicant | AIRLIFE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-05 |
Decision Date | 1980-10-31 |