COMPUTERIZED LABOR MONITORING SYSTEM
Device Facts
| Record ID | DEN060006 |
|---|---|
| Device Name | COMPUTERIZED LABOR MONITORING SYSTEM |
| Applicant | Barnev, Ltd. |
| Product Code | NPB · Ophthalmic |
| Decision Date | Jan 30, 2007 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 884.2800 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
