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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 K152029
Device Name HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, 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  
Date Received07/22/2015
Decision Date 05/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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