FDA.report

510(k) K081984

Device
LABORPRO SYSTEM
Applicant
TRIG MEDICAL LTD
510(k) number
K081984
Product code
NPB  
Decision
Substantially Equivalent (SESE)
Decision date
2009-03-04
Date received
2008-07-11
Regulation
884.2800
Classification name
System, Monitoring, For Progress Of Labor
Medical specialty
Ophthalmic
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
KEREN SHTIEGMAN
Address
7 Jabotinsky St. Moshe Aviv Bldg. Ramat-Gan IL 52520 52520

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code NPB  

510(k)DeviceApplicantDecision date
K082704BIRTHTRACK (A.K.A. CLM)Barnev, Ltd.2009-01-09
K080672BIRTHTRACKBarnev, Ltd.2008-07-08
DEN060006COMPUTERIZED LABOR MONITORING SYSTEMBarnev, Ltd.2007-01-30

Legacy Summary

summary

FDA Review

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