← Product Code [EWO](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO) · K940216

# BELTONE SERIES 100 AUDIOMETERS (K940216)

_Beltone Electronics Corp. · EWO · Jul 29, 1994 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K940216

## Device Facts

- **Applicant:** Beltone Electronics Corp.
- **Product Code:** [EWO](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO.md)
- **Decision Date:** Jul 29, 1994
- **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/K940216](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWO/K940216)

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