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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 K132407
Device Name VITAL SIGNS PATCH SYSTEM (IN SHORT VSP)
Applicant
LIFEWATCH TECHNOLOGIES LTD
2 PEKERIS STREET
rehovot,  IL 7670202
Applicant Contact asher kassel
Correspondent
LIFEWATCH TECHNOLOGIES LTD
2 PEKERIS STREET
rehovot,  IL 7670202
Correspondent Contact asher kassel
Regulation Number870.1025
Classification Product Code
DSI  
Date Received08/02/2013
Decision Date 12/19/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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