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FDA 510(k) Application Details - K002068
Device Classification Name
Detector And Alarm, Arrhythmia
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510(K) Number
K002068
Device Name
Detector And Alarm, Arrhythmia
Applicant
NIHON KOHDEN AMERICA, INC.
90 ICON ST.
FOOTHILL RANCH, CA 92610-1601 US
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BONNIE BISHOP
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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
07/07/2000
Decision Date
02/08/2001
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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