← Product Code [DXK](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK) · K812209

# ULTRA COM (K812209)

_Ultranamics, Inc. · DXK · Nov 16, 1981 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K812209

## Device Facts

- **Applicant:** Ultranamics, Inc.
- **Product Code:** [DXK](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK.md)
- **Decision Date:** Nov 16, 1981
- **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/K812209](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DXK/K812209)

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