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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(With Arrhythmia Detection Or Alarms)
510(k) Number K222586
Device Name Mural Clinical Viewer
Applicant
Ge Medical Systems Information Technologies, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact Brandon O'Shea
Correspondent
Ge Medical Systems Information Technologies, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact Brandon O'Shea
Regulation Number870.1025
Classification Product Code
MHX  
Date Received08/26/2022
Decision Date 12/21/2022
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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