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 884.2620](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2620) → HGO — Monitor, Electroencephalographic, Fetal (And Accessories)

# HGO · Monitor, Electroencephalographic, Fetal (And Accessories)

_Obstetrics/Gynecology · 21 CFR 884.2620 · Class 3_

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

## Overview

- **Product Code:** HGO
- **Device Name:** Monitor, Electroencephalographic, Fetal (And Accessories)
- **Regulation:** [21 CFR 884.2620](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2620)
- **Device Class:** 3
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## Identification

A fetal electroencephalographic monitor is a device used to detect, measure, and record in graphic form (by means of one or more electrodes placed transcervically on the fetal scalp during labor) the rhythmically varying electrical skin potentials produced by the fetal brain.

## Classification Rationale

Class III (premarket approval).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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