← Product Code [EWO](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO) · K780150

# NEONATAL SCREENING AUDIOMETER (K780150)

_Telediagnostic Systems, Inc. · EWO · Feb 13, 1978 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K780150

## Device Facts

- **Applicant:** Telediagnostic Systems, Inc.
- **Product Code:** [EWO](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO.md)
- **Decision Date:** Feb 13, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.1050
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K780150](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K780150)

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