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FDA 510(k) Application Details - K150398
Device Classification Name
System, Monitoring, Perinatal
More FDA Info for this Device
510(K) Number
K150398
Device Name
System, Monitoring, Perinatal
Applicant
OB TOOLS, LTD.
MIFALEY HAEMEK INDUSTRIAL ZONE
P.O. BOX 667
MIGDAL HA-EMEK 2310502 IL
Other 510(k) Applications for this Company
Contact
GAL BEN DAVID
Other 510(k) Applications for this Contact
Regulation Number
884.2740
More FDA Info for this Regulation Number
Classification Product Code
HGM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/18/2015
Decision Date
08/06/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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