FDA Product Code
FDA Product Code OSP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2720
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K190798 | LaborView LV1000 Wireless Electrode System | Obmedical Company | 2020-09-18 | Traditional | PDF ↗ |
| K153262 | PUREtrace | Nemo Healthcare BV | 2017-02-07 | Traditional | PDF ↗ |
| K142583 | LaborView LV1000 | Obmedical Company | 2015-01-16 | Traditional | PDF ↗ |
| K140862 | MONICA NOVII WIRELESS PATCH SYSTEM | Monica Healthcare, Ltd. | 2014-08-27 | Traditional | PDF ↗ |
| K131889 | EUM 100PRO | Promedic, Inc. | 2014-04-23 | Traditional | PDF ↗ |
| K130002 | SURECALL LABOR MONITOR | Reproductive Research Technologies, LP | 2013-06-28 | Traditional | PDF ↗ |
| K112390 | MONICA AN24 | Monica Healthcare, Ltd. | 2012-07-13 | Traditional | PDF ↗ |
| K112163 | MONICA IF24 | Monica Healthcare | 2011-08-30 | Traditional | PDF ↗ |
| K101801 | MONICA AN24 | Monica Healthcare | 2011-02-03 | Traditional | PDF ↗ |
| K090145 | SURECALL EMG LABOR MONITOR | Reproductive Research Technologies, LP | 2011-01-25 | Traditional | PDF ↗ |
Product code OSP · Class II · Obstetrics/Gynecology. Data: openFDA.