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FDA 510(k) Application Details - K970358
Device Classification Name
Detector And Alarm, Arrhythmia
More FDA Info for this Device
510(K) Number
K970358
Device Name
Detector And Alarm, Arrhythmia
Applicant
MENNEN MEDICAL, INC.
KIRYAT WEIZMANN SCIENCE PARK
P.O. BOX 102
REHOVOT 76100 IL
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Contact
ALAN SCHWEBEL PH.D.
Other 510(k) Applications for this Contact
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
01/30/1997
Decision Date
02/11/1998
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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