The following data is part of a premarket notification filed by Carefusion Inc with the FDA for Airlife Adult Heated Wire Circuit.
| Device ID | K153234 |
| 510k Number | K153234 |
| Device Name: | AirLife Adult Heated Wire Circuit |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | CAREFUSION INC 75 N FAIRWAY DRIVE Vernon Hills, IL 60060 1 |
| Contact | Erika Fernandez |
| Correspondent | Erika Fernandez CAREFUSION INC 75 N FAIRWAY DRIVE Vernon Hills, IL 60060 1 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-09 |
| Decision Date | 2016-07-07 |
| Summary: | summary |