The following data is part of a premarket notification filed by Airlife, Inc. with the FDA for Pediatric Oxygen Or Aerosol Masks,.
| Device ID | K802323 |
| 510k Number | K802323 |
| Device Name: | PEDIATRIC OXYGEN OR AEROSOL MASKS, |
| Classification | Mask, Oxygen |
| Applicant | AIRLIFE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-23 |
| Decision Date | 1980-10-03 |