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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 K193228
Device Name Hamilton-G5
Applicant
Hamilton Medical AG
Via Crush 8
Bonaduz,  CH 7402
Applicant Contact Simone Haller
Correspondent
Hamilton Medical AG
Via Crush 8
Bonaduz,  CH 7402
Correspondent Contact Simone Haller
Regulation Number868.5895
Classification Product Code
CBK  
Date Received11/22/2019
Decision Date 05/04/2020
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
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