Electroglottograph
An Electroglottograph is a non-invasive diagnostic instrument used in ear, nose, and throat medicine to assess vocal fold contact and vibration patterns by measuring electrical impedance changes at the larynx level, aiding in the evaluation of voice disorders. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KLX and it is regulated under 21 CFR 874.1325 in the Ear, Nose, and Throat specialty.
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Basic Information
- Product Code
- KLX
- Device Class
- FDA class 2
- Regulation Number
- 874.1325
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K990240 | ELECTROGLOTTOGRAPH | Mar 11, 1999 | Substantially Equivalent | Kay Elemetrics Corp. |
| K901609 | ELECTROGLOTTOGRAPH | Jun 28, 1990 | Substantially Equivalent | Glottal Ent., Inc. |
| K841832 | GLOTTAL FREQUENCY ANALYSER | Jul 18, 1984 | Substantially Equivalent | Teltec Electronic Equipment AB |
| K821079 | ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG | May 10, 1982 | Substantially Equivalent | Ms. Kate Teaney |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.