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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K121225
Device Name HAMILTON-C2
Applicant
HAMILTON MEDICAL AG
VIA CRUSCH 8
BONADUZ,  CH CH-7402
Applicant Contact RALPH AGUILA
Correspondent
HAMILTON MEDICAL AG
VIA CRUSCH 8
BONADUZ,  CH CH-7402
Correspondent Contact RALPH AGUILA
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/23/2012
Decision Date 11/16/2012
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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