← Product Code [HGP](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP) · K801984

# FE-3000 FETAL ELECTRODE, SPIRAL SYSTEM (K801984)

_Life Support, Inc. · HGP · Sep 9, 1980 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K801984

## Device Facts

- **Applicant:** Life Support, Inc.
- **Product Code:** [HGP](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP.md)
- **Decision Date:** Sep 9, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.2675
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery. It establishes electrical contact between fetal skin and an external monitoring device by a shallow subcutaneous puncture of fetal scalp tissue with a curved needle or needles. This generic type of device includes nonreusable spiral electrodes and reusable circular electrodes.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K801984](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K801984)

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