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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K103427
Device Name MOBILEECG SYSTEM
Applicant
Memtec Corp.
68 Stiles Rd. Unit D
Salem,  NH  03079
Applicant Contact DENNIS GARBOSKI
Correspondent
Memtec Corp.
68 Stiles Rd. Unit D
Salem,  NH  03079
Correspondent Contact DENNIS GARBOSKI
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/22/2010
Decision Date 03/24/2011
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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