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FDA 510(k) Application Details - K132407
Device Classification Name
Detector And Alarm, Arrhythmia
More FDA Info for this Device
510(K) Number
K132407
Device Name
Detector And Alarm, Arrhythmia
Applicant
LIFEWATCH TECHNOLOGIES LTD
2 PEKERIS STREET
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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More FDA Info for this Product Code
Date Received
08/02/2013
Decision Date
12/19/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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