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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 K153234
Device Name AirLife Adult Heated Wire Circuit
Applicant
Carefusion, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60060 1
Applicant Contact ERIKA FERNANDEZ
Correspondent
Carefusion, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60060 1
Correspondent Contact ERIKA FERNANDEZ
Regulation Number868.5270
Classification Product Code
BZE  
Date Received11/09/2015
Decision Date 07/07/2016
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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