The following data is part of a premarket notification filed by Carefusion with the FDA for Airlife Infant Heated Wire Circuit.
| Device ID | K151303 |
| 510k Number | K151303 |
| Device Name: | AirLife Infant Heated Wire Circuit |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | CAREFUSION 75 NORTH FAIRWAY DRIVE Vernon Hills, IL 60047 |
| Contact | Erika Fernandez |
| Correspondent | Erika Fernandez CAREFUSION 75 NORTH FAIRWAY DRIVE Vernon Hills, IL 60047 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2016-01-21 |
| Summary: | summary |