NPB · Class II · 21 CFR 884.2800

FDA Product Code NPB: System, Monitoring, For Progress Of Labor

This Monitoring System For Progress Of Labor Provides Intrapartum Measurement Of Cervical Dilation, Fetal Head Station, And/or Other Sentinel Anatomical Markers. This Device Is Intended To Be Used Adjunctively With Other Diagnostic Information In Order To Clinically Follow The Progress Of Labor.

Leading manufacturers include Barnev, Ltd. and Trig Medical, Ltd..

4
Total
3
Cleared
144d
Avg days
2007
Since

FDA 510(k) Cleared System, Monitoring, For Progress Of Labor Devices (Product Code NPB)

4 devices
1–4 of 4
Cleared Mar 04, 2009
LABORPRO SYSTEM
K081984
Trig Medical, Ltd.
Obstetrics & Gynecology · 236d
Cleared Jan 09, 2009
BIRTHTRACK (A.K.A. CLM)
K082704
Barnev, Ltd.
Obstetrics & Gynecology · 115d
Cleared Jul 08, 2008
BIRTHTRACK
K080672
Barnev, Ltd.
Obstetrics & Gynecology · 120d
Not Cleared Jan 30, 2007
COMPUTERIZED LABOR MONITORING SYSTEM
DEN060006
Barnev, Ltd.
Obstetrics & Gynecology · 104d

About Product Code NPB - Regulatory Context