← Product Code [KLX](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KLX) · K901609

# ELECTROGLOTTOGRAPH (K901609)

_Glottal Ent., Inc. · KLX · Jun 28, 1990 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KLX/K901609

## Device Facts

- **Applicant:** Glottal Ent., Inc.
- **Product Code:** [KLX](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KLX.md)
- **Decision Date:** Jun 28, 1990
- **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/K901609](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/KLX/K901609)

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