FDA 510(k) Application Details - K151835

Device Classification Name Detector And Alarm, Arrhythmia

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510(K) Number K151835
Device Name Detector And Alarm, Arrhythmia
Applicant LIFEWATCH TECHNOLOGIES LTD.
2 PEKERIS ST.
REHOVOT 7670202 IL
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Contact ASHER KASSEL
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Regulation Number 870.1025

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Classification Product Code DSI
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Date Received 07/06/2015
Decision Date 02/05/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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