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

Applicant Contact#

Contact: AHAVA STEIN
Address: 20 Hata'As St. Kfar Saba IL 44425 44425

Source Documents#

Other 510(k) Records For Product Code NPB #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K081984	LABORPRO SYSTEM	Trig Medical, Ltd.	2009-03-04
K080672	BIRTHTRACK	Barnev, Ltd.	2008-07-08
DEN060006	COMPUTERIZED LABOR MONITORING SYSTEM	Barnev, Ltd.	2007-01-30

Legacy Summary#

summary

FDA Review#

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