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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 K131699
Device Name EMOTION ECG MOBILE
Applicant
MEGA ELECTRONICS LTD.
Prinsessegracht 20
The Hague,  NL 2514 AP
Applicant Contact ANDRE KINDSVATER
Correspondent
MEGA ELECTRONICS LTD.
Prinsessegracht 20
The Hague,  NL 2514 AP
Correspondent Contact ANDRE KINDSVATER
Regulation Number870.2920
Classification Product Code
DXH  
Date Received06/11/2013
Decision Date 11/26/2013
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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