Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2860](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2860) → JOO — Transducer, Heart Sound

# JOO · Transducer, Heart Sound

_Cardiovascular · 21 CFR 870.2860 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOO

## Overview

- **Product Code:** JOO
- **Device Name:** Transducer, Heart Sound
- **Regulation:** [21 CFR 870.2860](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2860)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)
- **3rd-party reviewable:** yes

## Identification

A heart sound transducer is an external transducer that exhibits a change in mechanical or electrical properties in relation to sounds produced by the heart. This device may be used in conjunction with a phonocardiograph to record heart sounds.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOO](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/JOO)

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