The following data is part of a premarket notification filed by Carefusion Inc with the FDA for Airlife Infant Single Limb Heated Wire Circuit.
Device ID | K151959 |
510k Number | K151959 |
Device Name: | AirLife Infant Single Limb Heated Wire Circuit |
Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
Applicant | CAREFUSION INC 75 N FAIRWAY DRIVE Vernon Hills, IL 60061 |
Contact | Erika Fernandez |
Correspondent | Erika Fernandez CAREFUSION INC 75 N FAIRWAY DRIVE Vernon Hills, IL 60061 |
Product Code | BZE |
CFR Regulation Number | 868.5270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-16 |
Decision Date | 2016-01-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50885403288911 | K151959 | 000 |
50885403276192 | K151959 | 000 |