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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 K163283
Device Name HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
Applicant
HAMILTON MEDICAL AG
VIA CRUSCH 8
BONADUZ,  CH 7402
Applicant Contact Steffen Boden
Correspondent
HAMILTON MEDICAL AG
VIA CRUSCH 8
BONADUZ,  CH 7402
Correspondent Contact Steffen Boden
Regulation Number868.5450
Classification Product Code
BTT  
Subsequent Product Code
BZE  
Date Received11/21/2016
Decision Date 09/20/2017
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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