The following data is part of a premarket notification filed by Airlife, Inc. with the FDA for Humidifier W/ Or W/out Adaptor.
| Device ID | K811161 |
| 510k Number | K811161 |
| Device Name: | HUMIDIFIER W/ OR W/OUT ADAPTOR |
| Classification | Humidifier, Non-direct Patient Interface (home-use) |
| Applicant | AIRLIFE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KFZ |
| CFR Regulation Number | 868.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-28 |
| Decision Date | 1981-06-24 |