← Product Code [BZW](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW) · K800463

# ESOPHAGEAL STETHESCOPE (K800463)

_Medical Components, Inc. · BZW · Mar 10, 1980 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K800463

## Device Facts

- **Applicant:** Medical Components, Inc.
- **Product Code:** [BZW](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW.md)
- **Decision Date:** Mar 10, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.1910
- **Device Class:** Class 1
- **Review Panel:** Anesthesiology

## Regulatory Identification

An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen to heart and breath sounds.

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**Source:** [https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K800463](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K800463)

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