Panels › Obstetrics/Gynecology › Product code OSP · Class 2
Uterine Electromyographic Monitor
Regulation 884.2720
0510(k)s in 12 months (10 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in OSP
| Company | 510(k)s | Recalls |
|---|---|---|
| Monica Healthcare | 4 | 1 |
| GE Healthcare, LLC | 0 | 2 |
| Obmedical Company | 2 | 0 |
| Reproductive Research Technologies, LP | 2 | 0 |
| Nemo Healthcare BV | 1 | 0 |
| Promedic, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 18, 2020 | K190798 | LaborView LV1000 Wireless Electrode System Obmedical Company | OSP |
| Feb 7, 2017 | K153262 | PUREtrace Nemo Healthcare BV, NL | OSP |
| Jan 16, 2015 | K142583 | LaborView LV1000 Obmedical Company | OSP |
| Aug 27, 2014 | K140862 | MONICA NOVII WIRELESS PATCH SYSTEM Monica Healthcare, Ltd., GB | OSP |
| Apr 23, 2014 | K131889 | EUM 100PRO Promedic, Inc. | OSP |
| Jun 28, 2013 | K130002 | SURECALL LABOR MONITOR Reproductive Research Technologies, LP | OSP |
| Jul 13, 2012 | K112390 | MONICA AN24 Monica Healthcare, Ltd., GB | OSP |
| Aug 30, 2011 | K112163 | MONICA IF24 Monica Healthcare, GB | OSP |
| Feb 3, 2011 | K101801 | MONICA AN24 Monica Healthcare, GB | OSP |
| Jan 25, 2011 | K090145 | SURECALL EMG LABOR MONITOR Reproductive Research Technologies, LP | OSP |
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