NPB
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Monitoring, For Progress Of Labor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2800
- Medical specialty
- Ophthalmic
- FDA definition
- This monitoring system for progress of labor provides intrapartum measurement of cervical dilation, fetal head station, and/or other sentinel anatomical markers. This device is intended to be used adjunctively with other diagnostic information in order to clinically follow the progress of labor.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LABORPRO SYSTEM (K081984) | Trig Medical, Ltd. | 2009-03-04 |
| BIRTHTRACK (A.K.A. CLM) (K082704) | Barnev, Ltd. | 2009-01-09 |
| BIRTHTRACK (K080672) | Barnev, Ltd. | 2008-07-08 |
| COMPUTERIZED LABOR MONITORING SYSTEM (DEN060006) | Barnev, Ltd. | 2007-01-30 |
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