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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
Hamilton Medical AG
Via Crusch 8
Bonaduz,  CH 7402
Applicant Contact Simone Haller
Hamilton Medical AG
Via Crusch 8
Bonaduz,  CH 7402
Correspondent Contact Simone Haller
Regulation Number868.5895
Classification Product Code
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
Recalls CDRH Recalls