Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart B — Diagnostic Devices](/submissions/AN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 868.1930](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1930) → BZS — Stethoscope Head

# BZS · Stethoscope Head

_Anesthesiology · 21 CFR 868.1930 · Class 1_

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

## Overview

- **Product Code:** BZS
- **Device Name:** Stethoscope Head
- **Regulation:** [21 CFR 868.1930](/submissions/AN/subpart-b%E2%80%94diagnostic-devices/868.1930)
- **Device Class:** 1
- **Review Panel:** [Anesthesiology](/submissions/AN)

## Identification

A stethoscope head is a weighted chest piece used during anesthesia to listen to a patient's heart, breath, and other physiological 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 the limitations in § 868.9.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K935146](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZS/K935146.md) | DISPOSABLE STETHOSCOPE HEAD COVER | Modern Medical Devices, Inc. | Jul 11, 1994 | SESE |
| [K930118](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZS/K930118.md) | STETSKINS | Nova Diversified Concepts | Mar 26, 1993 | SESE |
| [K801050](https://fda.innolitics.com/submissions/AN/subpart-b%E2%80%94diagnostic-devices/BZS/K801050.md) | SUPRA SCOPE | Warner-Lambert Co. | May 14, 1980 | SESE |

## Top Applicants

- Modern Medical Devices, Inc. — 1 clearance
- Nova Diversified Concepts — 1 clearance
- Warner-Lambert Co. — 1 clearance

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

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