← Product Code [DXW](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXW) · K800179

# INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR (K800179)

_Sphygmetrics, Inc. · DXW · Feb 11, 1980 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXW/K800179

## Device Facts

- **Applicant:** Sphygmetrics, Inc.
- **Product Code:** [DXW](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXW.md)
- **Decision Date:** Feb 11, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1270
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the associated device that processes the signal from the transducer; this device records bioacoustic phenomena from a transducer placed within the heart, blood vessels, or body cavities.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXW/K800179](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DXW/K800179)

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