FDA.report

510(k) K082704

Device
BIRTHTRACK (A.K.A. CLM)
Applicant
BARNEV, LTD.
510(k) number
K082704
Product code
NPB  
Decision
Substantially Equivalent (SESE)
Decision date
2009-01-09
Date received
2008-09-16
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
AHAVA STEIN
Address
20 Hata'As St. Kfar Saba IL 44425 44425

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code NPB  

510(k)DeviceApplicantDecision date
K081984LABORPRO SYSTEMTrig Medical, Ltd.2009-03-04
K080672BIRTHTRACKBarnev, Ltd.2008-07-08
DEN060006COMPUTERIZED LABOR MONITORING SYSTEMBarnev, Ltd.2007-01-30

Legacy Summary

summary

FDA Review

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