← Product Code [DQC](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC) · K950537

# CARDIOPHONICS INCORPORATED DPS 2000 PHONOCARDIOGRAPH (K950537)

_Cardiophonics, Inc. · DQC · Mar 1, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K950537

## Device Facts

- **Applicant:** Cardiophonics, Inc.
- **Product Code:** [DQC](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC.md)
- **Decision Date:** Mar 1, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2390
- **Device Class:** Class 1
- **Review Panel:** Cardiovascular

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K950537](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K950537)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
