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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K192276
Device Name Merge Cardio
Applicant
Merge Healthcare Incorporated
900 Walnut Ridge Drive
Hartland,  WI  53209
Applicant Contact Lisa Baumhardt
Correspondent
Merge Healthcare Incorporated
900 Walnut Ridge Drive
Hartland,  WI  53209
Correspondent Contact Lisa Baumhardt
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/22/2019
Decision Date 09/20/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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