OSP

Uterine Electromyographic Monitor

Product code

OSP

Device name

Uterine Electromyographic Monitor

Device class

Class 2

21 CFR

21 CFR 884.2720

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification 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.

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