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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K151839
Device Name AMC Health VitalCaregiving System
Applicant
Amc Health
39 Broadway, Suite 540
New York,  NY  10006
Applicant Contact Jonathan Shankman
Correspondent
Amc Health
39 Broadway, Suite 540
New York,  NY  10006
Correspondent Contact Jonathan Shankman
Regulation Number870.2300
Classification Product Code
MWI  
Date Received07/06/2015
Decision Date 09/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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