← Product Code [EWO](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO) · K112992

# EARLOGIC OAE TESTER (K112992)

_Earlogic Corporation · EWO · Apr 20, 2012 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K112992

## Device Facts

- **Applicant:** Earlogic Corporation
- **Product Code:** [EWO](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO.md)
- **Decision Date:** Apr 20, 2012
- **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/K112992](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K112992)

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