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510(k) K151303

AirLife Infant Heated Wire Circuit by Care Fusion — Product Code BZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2016
Date Received
May 18, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Device Class
Class II
Regulation Number
868.5270
Review Panel
AN
Submission Type

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