FDA product code OSP

Uterine Electromyographic Monitor

Obstetrics/Gynecology·Class 2·21 CFR 884.2720
US regulatory classifications
US Product Code (FDA)
OSP
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 884.2720
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Medical specialty
Obstetrics/Gynecology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Uterine Electromyographic Monitor is a medical device type in the Obstetrics/Gynecology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.