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FDA 510(k) Application Details - K081984
Device Classification Name
System, Monitoring, For Progress Of Labor
More FDA Info for this Device
510(K) Number
K081984
Device Name
System, Monitoring, For Progress Of Labor
Applicant
TRIG MEDICAL LTD
7 JABOTINSKY STREET
MOSHE AVIV BUILDING
RAMAT-GAN 52520 IL
Other 510(k) Applications for this Company
Contact
KEREN SHTIEGMAN
Other 510(k) Applications for this Contact
Regulation Number
884.2800
More FDA Info for this Regulation Number
Classification Product Code
NPB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/11/2008
Decision Date
03/04/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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