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 884.2640](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2640) → HFP — Monitor, Phonocardiographic, Fetal

# HFP · Monitor, Phonocardiographic, Fetal

_Obstetrics/Gynecology · 21 CFR 884.2640 · Class 2_

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

## Overview

- **Product Code:** HFP
- **Device Name:** Monitor, Phonocardiographic, Fetal
- **Regulation:** [21 CFR 884.2640](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/884.2640)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **3rd-party reviewable:** yes

## Identification

A fetal phonocardiographic monitor is a device designed to detect, measure, and record fetal heart sounds electronically, in graphic form, and noninvasively, to ascertain fetal condition during labor. This generic type of device includes the following accessories: signal analysis and display equipment, patient and equipment supports, and other component parts.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

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

**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 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [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