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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 K231870
Device Name CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
Applicant
Ge Medical Systems Information Technologies, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact Manjunatha K N
Correspondent
Ge Medical Systems Information Technologies, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact Manjunatha K N
Regulation Number870.1425
Classification Product Code
DQK  
Date Received06/26/2023
Decision Date 12/13/2023
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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