NPB

System, Monitoring, For Progress Of Labor

Product code

NPB

Device name

System, Monitoring, For Progress Of Labor

Device class

Class 2

21 CFR

21 CFR 884.2800

Medical specialty

Ophthalmic

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).