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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 K151959
Device Name AirLife Infant Single Limb Heated Wire Circuit
Applicant
Carefusion, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact ERIKA FERNANDEZ
Correspondent
Carefusion, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact ERIKA FERNANDEZ
Regulation Number868.5270
Classification Product Code
BZE  
Date Received07/16/2015
Decision Date 01/20/2016
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
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