Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart B — Diagnostic Devices](/submissions/EN/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 874.1060](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1060) → EWC — Chamber, Acoustic (For Audiometric Testing)

# EWC · Chamber, Acoustic (For Audiometric Testing)

_Ear, Nose, Throat · 21 CFR 874.1060 · Class 1_

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

## Overview

- **Product Code:** EWC
- **Device Name:** Chamber, Acoustic (For Audiometric Testing)
- **Regulation:** [21 CFR 874.1060](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/874.1060)
- **Device Class:** 1
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)

## 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.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K823872](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWC/K823872.md) | EMERGENCY TRACHEOSTOMY KIT | Omnicon Medical Corp. | Jan 21, 1983 | SESE |
| [K822269](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/EWC/K822269.md) | NAGASHIMA SN SOUND-PROOF CHAMBER-HEARING | Kelleher Corp. | Sep 9, 1982 | SESE |

## Top Applicants

- Kelleher Corp. — 1 clearance
- Omnicon Medical Corp. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com