← Product Code [KLX](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KLX) · K821079

# ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG (K821079)

_Ms. Kate Teaney · KLX · May 10, 1982 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KLX/K821079

## Device Facts

- **Applicant:** Ms. Kate Teaney
- **Product Code:** [KLX](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KLX.md)
- **Decision Date:** May 10, 1982
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.1325
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An electroglottograph is an AC-powered device that employs a pair of electrodes that are placed in contact with the skin on both sides of the larynx and held in place by a collar. It is intended to measure the electrical impedance of the larynx to aid in assessing the degree of closure of the vocal cords, confirm larygeal diagnosis, aid behavioral treatment of voice disorders, and aid research concerning the laryngeal mechanism.

## Special Controls

*Classification.* Class II (special 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.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KLX/K821079](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KLX/K821079)

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