Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart C — Obstetrical and Gynecological Monitoring Devices](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices) → [21 CFR 884.2050](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2050) → HEO — Analyzer, Data, Obstetric

# HEO · Analyzer, Data, Obstetric

_Obstetrics/Gynecology · 21 CFR 884.2050 · Class 3_

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

## Overview

- **Product Code:** HEO
- **Device Name:** Analyzer, Data, Obstetric
- **Regulation:** [21 CFR 884.2050](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2050)
- **Device Class:** 3
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## Identification

An obstetric data analyzer (fetal status data analyzer) is a device used during labor to analyze electronic signal data obtained from fetal and maternal monitors. The obstetric data analyzer provides clinical diagnosis of fetal status and recommendations for labor management and clinical interventions. This generic type of device may include signal analysis and display equipment, electronic interfaces for other equipment, and power supplies and component parts.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P020001](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HEO/P020001.md) | STAN S31 FETAL HEART MONITOR | Neoventa Medical AB | Nov 1, 2005 | APPR |

## Top Applicants

- Neoventa Medical AB — 1 clearance

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

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