Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1910](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1910) → BZW — Stethoscope, Esophageal

# BZW · Stethoscope, Esophageal

_Anesthesiology · 21 CFR 868.1910 · Class 1_

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

## Overview

- **Product Code:** BZW
- **Device Name:** Stethoscope, Esophageal
- **Regulation:** [21 CFR 868.1910](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1910)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K874519](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K874519.md) | MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR | Mon-A-Therm, Inc. | Jan 29, 1988 | SESE |
| [K860558](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K860558.md) | ESOPHAGEAL STETHOSCOPE | Sharn, Inc. | Apr 1, 1986 | SESE |
| [K844444](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K844444.md) | ESOPHAGEAL STETHOSCOPE | Medical Parameters, Inc. | Jan 10, 1985 | SESE |
| [K843070](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K843070.md) | ESOPHAGEAL STETHOSCOPES | Primrose Medical, Inc. | Aug 24, 1984 | SESE |
| [K842865](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K842865.md) | ESOPHAGEAL STETHOSCOPE | Inmed Corp. | Aug 15, 1984 | SESE |
| [K841574](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K841574.md) | QUAZAR ESOPHAGEAL STETHOSCOPE | Axiom Medical, Inc. | Aug 15, 1984 | SESE |
| [K830329](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K830329.md) | ESOPHAGEAL STETHOSCOPE | Science Development Corp. | Mar 11, 1983 | SESE |
| [K830218](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K830218.md) | SHERIDAN/ESOPHAGEAL STETHOSCOPE | Sheridan Catheter Corp. | Mar 9, 1983 | SESE |
| [K823703](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K823703.md) | ESOPHAGEAL STETHOSCOPE | Rsp, Inc. | Jan 7, 1983 | SESE |
| [K823126](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K823126.md) | MODEL SA-1 STETHOSCOPE AUDIO AMPLIFIER | Electromedics, Inc. | Nov 16, 1982 | SESE |
| [K800463](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K800463.md) | ESOPHAGEAL STETHESCOPE | Medical Components, Inc. | Mar 10, 1980 | SESE |
| [K790523](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K790523.md) | ARGYLE ESOPHAGEAL STETHOSCOPE | Sherwood Medical Industries | Mar 27, 1979 | SESE |
| [K771411](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZW/K771411.md) | ESOPHAGEAL STETH. TEMP. SENSOR | Labarge, Inc. | Sep 23, 1977 | SESE |

## Top Applicants

- Axiom Medical, Inc. — 1 clearance
- Electromedics, Inc. — 1 clearance
- Inmed Corp. — 1 clearance
- Labarge, Inc. — 1 clearance
- Medical Components, Inc. — 1 clearance

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

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