NPB · System, Monitoring, For Progress Of Labor
Ophthalmic · 21 CFR 884.2800 · Class 2
Overview
| Product Code | NPB |
|---|---|
| Device Name | System, Monitoring, For Progress Of Labor |
| Regulation | 21 CFR 884.2800 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
A computerized labor monitoring system is a system intended to continuously measure cervical dilation and fetal head descent and provide a display that indicates the progress of labor. The computerized labor monitoring system includes a monitor and ultrasound transducers. Ultrasound transducers are placed on the maternal abdomen and cervix and on the fetal scalp to provide the matrix of measurements used to produce the display.
Classification Rationale
Class II (special controls). The special controls are the FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems.” See § 884.1(e) for availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special controls are the FDA guidance document entitled: “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems.” See § 884.1(e) for availability of this guidance document.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K081984 | LABORPRO SYSTEM | Trig Medical, Ltd. | Mar 4, 2009 | SESE |
| K082704 | BIRTHTRACK (A.K.A. CLM) | Barnev, Ltd. | Jan 9, 2009 | SESE |
| K080672 | BIRTHTRACK | Barnev, Ltd. | Jul 8, 2008 | SESE |
| DEN060006 | COMPUTERIZED LABOR MONITORING SYSTEM | Barnev, Ltd. | Jan 30, 2007 | DENG |
Top Applicants
- Barnev, Ltd. — 3 clearances
- Trig Medical, Ltd. — 1 clearance
