← Product Code [ESE](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESE) · K934483

# NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX (K934483)

_Mountain Precision Mfg. Ltd. Co. · ESE · Mar 16, 1994 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESE/K934483

## Device Facts

- **Applicant:** Mountain Precision Mfg. Ltd. Co.
- **Product Code:** [ESE](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESE.md)
- **Decision Date:** Mar 16, 1994
- **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/K934483](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/ESE/K934483)

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