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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 K120670
Device Name HAMILTON-T1
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 Received03/05/2012
Decision Date 04/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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