← Product Code [NPB](/submissions/OP/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NPB) · DEN060006

# COMPUTERIZED LABOR MONITORING SYSTEM (DEN060006)

_Barnev, Ltd. · NPB · Jan 30, 2007 · Ophthalmic · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NPB/DEN060006

## Device Facts

- **Applicant:** Barnev, Ltd.
- **Product Code:** [NPB](/submissions/OP/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NPB.md)
- **Decision Date:** Jan 30, 2007
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 884.2800
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NPB/DEN060006](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/NPB/DEN060006)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a De Novo](https://innolitics.com/services/regulatory/), [a 510(k)](https://innolitics.com/services/510ks/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com