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OSP — Uterine Electromyographic Monitor Class II

FDA Device Classification

Classification Details

Product Code
OSP
Device Class
Class II
Regulation Number
884.2720
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K190798obmedicalLaborView™ LV1000 Wireless Electrode SystemSeptember 18, 2020
K153262nemo healthcarePUREtrace™February 7, 2017
K142583obmedicalLaborView LV1000January 16, 2015
K140862monica healthcareMONICA NOVII WIRELESS PATCH SYSTEMAugust 27, 2014
K131889promedicEUM 100PROApril 23, 2014
K130002reproductive research technologiesSURECALL LABOR MONITORJune 28, 2013
K112390monica healthcareMONICA AN24July 13, 2012
K112163monica healthcareMONICA IF24August 30, 2011
K101801monica healthcareMONICA AN24February 3, 2011
K090145reproductive research technologiesSURECALL EMG LABOR MONITORJanuary 25, 2011