The following data is part of a premarket notification filed by Airlife, Inc. with the FDA for Single Use Nebulizer-adjust-air Entrain.
| Device ID | K834077 |
| 510k Number | K834077 |
| Device Name: | SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AIRLIFE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-25 |
| Decision Date | 1983-12-12 |