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Uterine Electromyographic Monitor

FDA product code OSP · 7 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 884.2720
Review panel
OB
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2011-01-25 – 2020-09-18

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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