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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 K180295
Device Name Hamilton-G5
Applicant
Hamiton Medical AG
Via Crusch 8
Bonaduz,  CH 7402
Applicant Contact Frederick Bruhschwein-Mandic
Correspondent
Hamiton Medical AG
Via Crusch 8
Bonaduz,  CH 7402
Correspondent Contact Frederick Bruhschwein-Mandic
Regulation Number868.5895
Classification Product Code
CBK  
Date Received02/01/2018
Decision Date 07/30/2019
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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