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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 K233326
Device Name Merge Hemo, Model RCSV2
Applicant
Merge Healthcare Incorporated
900 Walnut Ridge Dr.
Hartland,  WI  53029
Applicant Contact Carol Nakagawa
Correspondent
Merge Healthcare Incorporated
900 Walnut Ridge Dr.
Hartland,  WI  53029
Correspondent Contact Carol Nakagawa
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/29/2023
Decision Date 06/21/2024
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
Recalls CDRH Recalls
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