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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 K181658
Device Name MobileECG 2 BT
Applicant
Memtec Corporation
68 Stiles Rd. Unit D
Salem,  NH  03079
Applicant Contact Dennis Garboski
Correspondent
Memtec Corporation
68 Stiles Rd. Unit D
Salem,  NH  03079
Correspondent Contact Dennis Garboski
Regulation Number870.1025
Classification Product Code
DSI  
Subsequent Product Code
MWJ  
Date Received06/25/2018
Decision Date 03/26/2019
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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