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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 K190008
Device Name Carescape One
Applicant
GE Healthcare
8200 West Tower Avenue
Milwaukee,  WI  53223
Applicant Contact Joel Kent
Correspondent
GE Healthcare
8200 West Tower Avenue
Milwaukee,  WI  53223
Correspondent Contact Joel Kent
Regulation Number870.1025
Classification Product Code
MHX  
Date Received01/02/2019
Decision Date 12/20/2019
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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