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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, 
Contact ralph aguila
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/23/2012
Decision Date 11/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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