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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 K161450
Device Name HAMILTON-C3
Applicant
HAMILTON MEDICAL AG
VIA CRUSCH 8
BONADUZ,  CH 7402
Applicant Contact Katrin Vogt
Correspondent
HAMILTON MEDICAL AG
VIA CRUSCH 8
BONADUZ,  CH 7402
Correspondent Contact Katrin Vogt
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
DQA  
Date Received05/25/2016
Decision Date 04/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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