The following data is part of a premarket notification filed by Airlife, Inc. with the FDA for Adult & Pediatric Tracheostomy Masks.
| Device ID | K810946 |
| 510k Number | K810946 |
| Device Name: | ADULT & PEDIATRIC TRACHEOSTOMY MASKS |
| Classification | Mask, Oxygen, Low Concentration, Venturi |
| Applicant | AIRLIFE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYF |
| CFR Regulation Number | 868.5600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-07 |
| Decision Date | 1981-06-02 |