Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2390](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2390) → DQC — Phonocardiograph

# DQC · Phonocardiograph

_Cardiovascular · 21 CFR 870.2390 · Class 1_

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

## Overview

- **Product Code:** DQC
- **Device Name:** Phonocardiograph
- **Regulation:** [21 CFR 870.2390](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2390)
- **Device Class:** 1
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A phonocardiograph is a device used to amplify or condition the signal from a heart sound transducer. This device furnishes the excitation energy for the transducer and provides a visual or audible display of the heart 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 § 870.9.

## Recent Cleared Devices (18 of 18)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K950537](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K950537.md) | CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH | Cardiophonics, Inc. | Mar 1, 1996 | SESE |
| [K952651](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K952651.md) | LIFE SOUND SENSOR | Flowscan, Inc. | Sep 19, 1995 | SESE |
| [K943726](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K943726.md) | ACOUSTIC RECORDER | Technology Applications Assoc., Inc. | Nov 30, 1994 | SESE |
| [K924054](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K924054.md) | PHONOCARDIOGRAPH | Echo Ultrasound | Jan 22, 1993 | SESE |
| [K902185](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K902185.md) | DYNAMIC SPECTRAL PHONOCARDIOGRAPH | Reeves Scientific, Inc. | Mar 25, 1991 | SESE |
| [K900560](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K900560.md) | ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE | Acuson Corp. | Dec 3, 1990 | SESE |
| [K900365](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K900365.md) | PAG MICROPROCESSOR-CONTROLLED MODULE | Life Sciences Manufacturing, Inc. | Jul 18, 1990 | SESE |
| [K873640](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K873640.md) | MODIFIED DSP100 AMPLIFIER | Intl. Acoustics, Inc. | Dec 7, 1987 | SESE |
| [K870545](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K870545.md) | ANDRIES PHYSICAL ASSESSMENT COMPUTER | Andries Tek, Inc. | Aug 14, 1987 | SESE |
| [K864429](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K864429.md) | DSP100 CAROTID PHONOANGIOGRAPHY MODULE | Intl. Acoustics, Inc. | May 12, 1987 | SESE |
| [K860814](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K860814.md) | DSP100 AMPLIFIER | Intl. Acoustics, Inc. | Dec 5, 1986 | SESE |
| [K832679](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K832679.md) | NON-INVASIVE CLINICAL VASCULAR LAB | Life Sciences Manufacturing, Inc. | Jan 3, 1984 | SESE |
| [K811626](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K811626.md) | MEDDARS/ULTRA IMAGER PULSE/PHON MODULE | Honeywell, Inc. | Jul 1, 1981 | SESE |
| [K800655](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K800655.md) | MODEL 100 SPECTRAVIEW | Edwards Laboratories | Apr 16, 1980 | SESE |
| [K792466](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K792466.md) | NIC-200 VENTRICULAR FUNCTION ANALYZER | Nicolet Biomedical Instruments | Jan 24, 1980 | SESE |
| [K780116](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K780116.md) | AMPLIFIER, PC-700 | Burdick Corp. | Feb 24, 1978 | SESE |
| [K770757](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K770757.md) | PULSE/PHONOCARDIOGRAPHY CHANNEL, 144 | Honeywell, Inc. | May 9, 1977 | SESE |
| [K760464](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K760464.md) | PHON/STRESS SYSTEM (#21126A) | Hewlett-Packard Co. | Aug 30, 1976 | SESE |

## Top Applicants

- Intl. Acoustics, Inc. — 3 clearances
- Honeywell, Inc. — 2 clearances
- Life Sciences Manufacturing, Inc. — 2 clearances
- Acuson Corp. — 1 clearance
- Andries Tek, Inc. — 1 clearance

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

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