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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory, With Analysis Algorithm
510(k) Number K140847
FOIA Releasable 510(k) K140847
Device Name CARDIOSPY ECG HOLTER SYSTEMS
Applicant
Labtech Kft.
Vagu 4
Debrecen,  HU 4031
Applicant Contact ZSOLT KATONAI
Correspondent
Labtech Kft.
Vagu 4
Debrecen,  HU 4031
Correspondent Contact ZSOLT KATONAI
Regulation Number870.2800
Classification Product Code
MLO  
Date Received04/03/2014
Decision Date 12/05/2014
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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