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FDA 510(k) Application Details - K093766
Device Classification Name
Detector And Alarm, Arrhythmia
More FDA Info for this Device
510(K) Number
K093766
Device Name
Detector And Alarm, Arrhythmia
Applicant
MENNEN MEDICAL LTD.
4 HA-YARDEN ST.
P.O. BOX 102
YAVNE, REHOVOT 76100 IL
Other 510(k) Applications for this Company
Contact
IFAT OREN SHWARTS
Other 510(k) Applications for this Contact
Regulation Number
870.1025
More FDA Info for this Regulation Number
Classification Product Code
DSI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/07/2009
Decision Date
05/07/2010
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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