ELECTROGLOTTOGRAPH
FDA 510(k) clearance K990240 · decided 1999-03-11
Clearance details
- K-number
- K990240
- Device name
- ELECTROGLOTTOGRAPH
- Applicant
- Kay Elemetrics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-25
- Decision date
- 1999-03-11
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- KLX
- Device class
- 2
- Regulation number
- 874.1325
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Lincoln Park, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ELECTROGLOTTOGRAPH (K901609) | Glottal Ent., Inc. | 1990-06-28 |
| GLOTTAL FREQUENCY ANALYSER (K841832) | Teltec Electronic Equipment AB | 1984-07-18 |
| ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG (K821079) | Ms. Kate Teaney | 1982-05-10 |
Recalls involving this device
No recalls on record reference this clearance.