DeviceClearance

Product code OSP— Obstetrics/Gynecology

MONICA AN24

Classification name
Uterine Electromyographic Monitor
Device class
Class 2
Regulation
21 CFR 884.2720
Advisory panel
Obstetrics/Gynecology
Total cleared
10
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OSP under 21 CFR 884.2720, via openFDA

Market context for product code OSP

FDA has cleared 10 devices under product code OSP between 2011 and 2020, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OSP

Recent clearances under product code OSP

Data sourced from openFDA. This site is unofficial and independent of the FDA.