Product code OSP

Device name

Uterine Electromyographic Monitor

Medical specialty

Obstetrics/Gynecology

Device class

2

Regulation number

884.2720

Review panel

OB

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

The uterine electromyographic monitor is intended to pick up uterine emg signals from surface electrodes placed on the maternal abdomen. It produces a uterine activity tracing and monitors women in labor at term gestation with a singleton pregnancy.

Source

FDA openFDA device classification dataset