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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K152701
Device Name Matrix Mini ECG Monitor
Applicant
Global Instrumentation, LLC
8104 Cazenovia Rd.
Manlius,  NY  13104
Applicant Contact CRAIG SELLERS
Correspondent
Global Instrumentation, LLC
8104 Cazenovia Rd.
Manlius,  NY  13104
Correspondent Contact CRAIG SELLERS
Regulation Number870.1025
Classification Product Code
DSI  
Date Received09/21/2015
Decision Date 04/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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