OSP
10 FDA 510(k) clearances · Product code
302 daysmedian time to decision
734 days90th percentile
10clearances measured
FDA profile
- Official device name
- Uterine Electromyographic Monitor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2720
- Medical specialty
- Obstetrics/Gynecology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| LaborView™ LV1000 Wireless Electrode System (K190798) | Obmedical Company | 2020-09-18 |
| PUREtrace™ (K153262) | Nemo Healthcare BV | 2017-02-07 |
| LaborView LV1000 (K142583) | Obmedical Company | 2015-01-16 |
| MONICA NOVII WIRELESS PATCH SYSTEM (K140862) | Monica Healthcare, Ltd. | 2014-08-27 |
| EUM 100PRO (K131889) | Promedic, Inc. | 2014-04-23 |
| SURECALL LABOR MONITOR (K130002) | Reproductive Research Technologies, LP | 2013-06-28 |
| MONICA AN24 (K112390) | Monica Healthcare, Ltd. | 2012-07-13 |
| MONICA IF24 (K112163) | Monica Healthcare | 2011-08-30 |
| MONICA AN24 (K101801) | Monica Healthcare | 2011-02-03 |
| SURECALL EMG LABOR MONITOR (K090145) | Reproductive Research Technologies, LP | 2011-01-25 |
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Every clearance here is in the API, with alerts when new ones post.