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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K160764
Device Name AirLife Autofill Humidification Chamber
Applicant
Carefusion 2200, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact ERIKA FERNANDEZ
Correspondent
Carefusion 2200, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact ERIKA FERNANDEZ
Regulation Number868.5450
Classification Product Code
BTT  
Date Received03/21/2016
Decision Date 08/25/2016
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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