← Product Code [HGP](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP) · K901152

# REDYPLATE DISPOSABLE LEG PLATE (K901152)

_Medical Accessories, Inc. · HGP · Apr 4, 1990 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K901152

## Device Facts

- **Applicant:** Medical Accessories, Inc.
- **Product Code:** [HGP](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP.md)
- **Decision Date:** Apr 4, 1990
- **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/K901152](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGP/K901152)

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