← Product Code [EWO](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO) · K930003

# TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES (K930003)

_Etymotic Research · EWO · Jun 18, 1993 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K930003

## Device Facts

- **Applicant:** Etymotic Research
- **Product Code:** [EWO](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO.md)
- **Decision Date:** Jun 18, 1993
- **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/K930003](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K930003)

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