← Product Code [DQC](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC) · K800655

# MODEL 100 SPECTRAVIEW (K800655)

_Edwards Laboratories · DQC · Apr 16, 1980 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K800655

## Device Facts

- **Applicant:** Edwards Laboratories
- **Product Code:** [DQC](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC.md)
- **Decision Date:** Apr 16, 1980
- **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.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K800655](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DQC/K800655)

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