Electroglottograph
510(k) K990240
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990240 | Date11 Mar 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KLX
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.1325
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Electroglottograph is a diagnostic device classified as an electroglottograph (FDA product code KLX), designed to measure and analyze the electrical impedance changes across the neck during vocal fold vibrations. It provides objective data on vocal fold contact patterns, vocal fold movement, and glottal function, aiding in the assessment of voice disorders, dysphonia, and laryngeal pathologies. The device is primarily used in clinical settings by speech-language pathologists and otolaryngologists to evaluate vocal health and diagnose abnormalities in vocal fold function.
The Electroglottograph is supplied as a reusable medical device and is intended for use in clinical environments such as speech and hearing clinics, otolaryngology offices, and voice rehabilitation centers. It operates on the principle of measuring electrical impedance through the neck, requiring no sterilization between uses but adhering to standard infection control protocols. The device is regulated under FDA 510(k) clearance (K990240) as a Class II device under the Ear, Nose, and Throat category, with no specific MRI safety restrictions stated. Storage and maintenance follow manufacturer guidelines to ensure accurate and reliable performance.