Product code NPB

Device name

System, Monitoring, For Progress Of Labor

Medical specialty

Ophthalmic

Device class

2

Regulation number

884.2800

Review panel

OB

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset