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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 K201306
Device Name HAMILTON-C3
Applicant
Hamilton Medical AG
Via Crusch 8
Bonaduz,  CH 7402
Applicant Contact Simone Haller
Correspondent
Hamilton Medical AG
Via Crusch 8
Bonaduz,  CH 7402
Correspondent Contact Simone Haller
Regulation Number868.5895
Classification Product Code
CBK  
Date Received05/15/2020
Decision Date 02/05/2021
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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