KLX · Electroglottograph
Ear, Nose, Throat · 21 CFR 874.1325 · Class 2
Overview
| Product Code | KLX |
|---|---|
| Device Name | Electroglottograph |
| Regulation | 21 CFR 874.1325 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K990240 | ELECTROGLOTTOGRAPH | Kay Elemetrics Corp. | Mar 11, 1999 | SESE |
| K901609 | ELECTROGLOTTOGRAPH | Glottal Ent., Inc. | Jun 28, 1990 | SESE |
| K841832 | GLOTTAL FREQUENCY ANALYSER | Teltec Electronic Equipment AB | Jul 18, 1984 | SESE |
| K821079 | ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG | Ms. Kate Teaney | May 10, 1982 | SESE |
Top Applicants
- Glottal Ent., Inc. — 1 clearance
- Kay Elemetrics Corp. — 1 clearance
- Ms. Kate Teaney — 1 clearance
- Teltec Electronic Equipment AB — 1 clearance
