← Product Code [DXK](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK) · K873032

# GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN (K873032)

_Biosound, Inc. · DXK · Feb 18, 1988 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K873032

## Device Facts

- **Applicant:** Biosound, Inc.
- **Product Code:** [DXK](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK.md)
- **Decision Date:** Feb 18, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.2330
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K873032](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K873032)

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