← Product Code [HGN](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGN) · K761338

# LEFF STETHOSCOPE FOR FETAL HEART (K761338)

_J. Sklar Mfg. Co., Inc. · HGN · Jan 12, 1977 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGN/K761338

## Device Facts

- **Applicant:** J. Sklar Mfg. Co., Inc.
- **Product Code:** [HGN](/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGN.md)
- **Decision Date:** Jan 12, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.2900
- **Device Class:** Class 1
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A fetal stethoscope is a device used for listening to fetal heart sounds. It is designed to transmit the fetal heart sounds not only through sound channels by air conduction, but also through the user's head by tissue conduction into the user's ears. It does not use ultrasonic energy. This device is designed to eliminate noise interference commonly caused by handling conventional stethoscopes.

---

**Source:** [https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGN/K761338](https://fda.innolitics.com/submissions/OB/subpart-c%E2%80%94obstetrical-and-gynecological-monitoring-devices/HGN/K761338)

**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