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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
Original Applicant
HAMILTON MEDICAL AG
via crusch 8
bonaduz,  SZ ch-7402
Original 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
Recalls CDRH Recalls
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