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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K151303
Device Name AirLife Infant Heated Wire Circuit
Applicant
Care Fusion
75 N Fairway Dr.
Vernon Hills,  IL  60047
Applicant Contact ERIKA FERNANDEZ
Correspondent
Care Fusion
75 N Fairway Dr.
Vernon Hills,  IL  60047
Correspondent Contact ERIKA FERNANDEZ
Regulation Number868.5270
Classification Product Code
BZE  
Date Received05/18/2015
Decision Date 01/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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