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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 K172510
Device Name µCor Heart Failure and Arrhythmia Management System
Applicant
ZOLL Manufacturing Corporation
121 Gamma Drive
pittsburgh,  PA  15238
Applicant Contact dawn chang
Correspondent
ZOLL Manufacturing Corporation
2000 Ringwood Avenue
san jose,  CA  95131
Correspondent Contact dawn chang
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DSB   DSI  
Date Received08/21/2017
Decision Date 05/11/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Clinical Trials NCT02975050
NCT03072732
Reviewed by Third Party No
Combination Product No
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