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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
ZOLL Manufacturing Corporation
121 Gamma Drive
Pittsburgh,  PA  15238
Applicant Contact Dawn Chang
ZOLL Manufacturing Corporation
2000 Ringwood Avenue
San Jose,  CA  95131
Correspondent Contact Dawn Chang
Regulation Number870.1025
Classification Product Code
Subsequent Product Codes
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
Reviewed by Third Party No
Combination Product No