← Product Code [ESE](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESE) · K823118

# SAY (K823118)

_Kells Medical, Inc. · ESE · Jan 7, 1983 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESE/K823118

## Device Facts

- **Applicant:** Kells Medical, Inc.
- **Product Code:** [ESE](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESE.md)
- **Decision Date:** Jan 7, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3375
- **Device Class:** Class 1
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

A battery-powered artificial larynx is an externally applied device intended for use in the absence of the larynx to produce sound. When held against the skin in the area of the voicebox, the device generates mechanical vibrations which resonate in the oral and nasal cavities and can be modulated by the tongue and lips in a normal manner, thereby allowing the production of speech.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESE/K823118](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESE/K823118)

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