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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, programmable
510(k) Number K152864
Device Name Merge Hemo
Applicant
MERGE HEALTHCARE INCORPORATED
900 WALNUT RIDGE DRIVE
HARTLAND,  WI  53029
Applicant Contact MIKE DIEDRICK
Correspondent
MERGE HEALTHCARE INCORPORATED
6303 AIRPORT ROAD, SUITE 500
MISSISSAUGA,  CA L4V1R8
Correspondent Contact CAROL NAKAGAWA
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/30/2015
Decision Date 04/07/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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