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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name transmitters and receivers, electrocardiograph, telephone
510(k) Number K143032
Device Name eMotion Faros ECG Mobile
Applicant
MEGA ELECTRONICS LTD.
PIONEERINKATU 6
KUOPIO,  FI 70800
Applicant Contact Taneli Vaaraniemi
Correspondent
MEGA ELECTRONICS LTD.
PIONEERINKATU 6
KUOPIO,  FI 70800
Correspondent Contact Taneli Vaaraniemi
Regulation Number870.2920
Classification Product Code
DXH  
Date Received10/22/2014
Decision Date 03/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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