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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 K153046
Device Name HAMILTON-MR1
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  
Date Received10/19/2015
Decision Date 09/06/2016
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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