OSP · Uterine Electromyographic Monitor
Obstetrics/Gynecology · 21 CFR 884.2720 · Class 2
Overview
| Product Code | OSP |
|---|---|
| Device Name | Uterine Electromyographic Monitor |
| Regulation | 21 CFR 884.2720 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190798 | LaborView LV1000 Wireless Electrode System | Obmedical Company | Sep 18, 2020 | SESE |
| K153262 | PUREtrace | Nemo Healthcare BV | Feb 7, 2017 | SESE |
| K142583 | LaborView LV1000 | Obmedical Company | Jan 16, 2015 | SESE |
| K140862 | MONICA NOVII WIRELESS PATCH SYSTEM | Monica Healthcare, Ltd. | Aug 27, 2014 | SESE |
| K131889 | EUM 100PRO | Promedic, Inc. | Apr 23, 2014 | SESE |
| K130002 | SURECALL LABOR MONITOR | Reproductive Research Technologies, LP | Jun 28, 2013 | SESE |
| K112390 | MONICA AN24 | Monica Healthcare, Ltd. | Jul 13, 2012 | SESE |
| K112163 | MONICA IF24 | Monica Healthcare | Aug 30, 2011 | SESE |
| K101801 | MONICA AN24 | Monica Healthcare | Feb 3, 2011 | SESE |
| K090145 | SURECALL EMG LABOR MONITOR | Reproductive Research Technologies, LP | Jan 25, 2011 | SESE |
Top Applicants
- Monica Healthcare — 2 clearances
- Monica Healthcare, Ltd. — 2 clearances
- Obmedical Company — 2 clearances
- Reproductive Research Technologies, LP — 2 clearances
- Nemo Healthcare BV — 1 clearance
