← Product Code [EWC](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWC) · K822269

# NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING (K822269)

_Kelleher Corp. · EWC · Sep 9, 1982 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWC/K822269

## Device Facts

- **Applicant:** Kelleher Corp.
- **Product Code:** [EWC](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWC.md)
- **Decision Date:** Sep 9, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.1060
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWC/K822269](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWC/K822269)

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