OSP — Uterine Electromyographic Monitor Class II
FDA product code OSP covers "Uterine Electromyographic Monitor", a Class II medical device regulated under 21 CFR 884.2720. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OSP
- Device Class
- Class II
- Regulation Number
- 884.2720
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K190798 | Obmedical | LaborView LV1000 Wireless Electrode System | Sep 18, 2020 |
| K153262 | Nemo Healthcare | PUREtrace | Feb 7, 2017 |
| K142583 | Obmedical | LaborView LV1000 | Jan 16, 2015 |
| K140862 | Monica Healthcare | MONICA NOVII WIRELESS PATCH SYSTEM | Aug 27, 2014 |
| K131889 | Promedic | EUM 100PRO | Apr 23, 2014 |
| K130002 | Reproductive Research Technologies | SURECALL LABOR MONITOR | Jun 28, 2013 |
| K112390 | Monica Healthcare | MONICA AN24 | Jul 13, 2012 |
| K112163 | Monica Healthcare | MONICA IF24 | Aug 30, 2011 |
| K101801 | Monica Healthcare | MONICA AN24 | Feb 3, 2011 |
| K090145 | Reproductive Research Technologies | SURECALL EMG LABOR MONITOR | Jan 25, 2011 |