KLX — Electroglottograph Class II
FDA product code KLX covers "Electroglottograph", a Class II medical device regulated under 21 CFR 874.1325. Submissions are reviewed by the Ear, Nose, Throat panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KLX
- Device Class
- Class II
- Regulation Number
- 874.1325
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K990240 | kay elemetrics | ELECTROGLOTTOGRAPH | March 11, 1999 |
| K901609 | glottal ent | ELECTROGLOTTOGRAPH | June 28, 1990 |
| K841832 | teltec electronic equipment | GLOTTAL FREQUENCY ANALYSER | July 18, 1984 |
| K821079 | kate teaney | ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG | May 10, 1982 |