OSP · Class II · 21 CFR 884.2720

FDA Product Code OSP: Uterine Electromyographic Monitor

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.

Leading manufacturers include Monica Healthcare, Ltd., Obmedical Company and Monica Healthcare.

10
Total
10
Cleared
306d
Avg days
2011
Since

FDA 510(k) Cleared Uterine Electromyographic Monitor Devices (Product Code OSP)

10 devices
1–10 of 10
Cleared Sep 18, 2020
LaborView™ LV1000 Wireless Electrode System
K190798
Obmedical Company
Obstetrics & Gynecology · 540d
Cleared Feb 07, 2017
PUREtrace™
K153262
Nemo Healthcare BV
Obstetrics & Gynecology · 455d
Cleared Jan 16, 2015
LaborView LV1000
K142583
Obmedical Company
Obstetrics & Gynecology · 123d
Cleared Aug 27, 2014
MONICA NOVII WIRELESS PATCH SYSTEM
K140862
Monica Healthcare, Ltd.
Obstetrics & Gynecology · 146d
Cleared Apr 23, 2014
EUM 100PRO
K131889
Promedic, Inc.
Obstetrics & Gynecology · 302d
Cleared Jun 28, 2013
SURECALL LABOR MONITOR
K130002
Reproductive Research Technologies, LP
Obstetrics & Gynecology · 177d
Cleared Jul 13, 2012
MONICA AN24
K112390
Monica Healthcare, Ltd.
Obstetrics & Gynecology · 330d
Cleared Aug 30, 2011
MONICA IF24
K112163
Monica Healthcare
Obstetrics & Gynecology · 34d

About Product Code OSP - Regulatory Context