The following data is part of a premarket notification filed by Carefusion 2200, Inc. with the FDA for Airlife Autofill Humidification Chamber.
| Device ID | K160764 |
| 510k Number | K160764 |
| Device Name: | AirLife Autofill Humidification Chamber |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | CAREFUSION 2200, INC. 75 N. FAIRWAY DR. Vernon Hills, IL 60061 |
| Contact | Erika Fernandez |
| Correspondent | Erika Fernandez CAREFUSION 2200, INC. 75 N. FAIRWAY DR. Vernon Hills, IL 60061 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-21 |
| Decision Date | 2016-08-25 |
| Summary: | summary |