ELECTROGLOTTOGRAPH
FDA 510(k) clearance K901609 · decided 1990-06-28
Clearance details
- K-number
- K901609
- Device name
- ELECTROGLOTTOGRAPH
- Applicant
- Glottal Ent., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-06
- Decision date
- 1990-06-28
- Days to decision
- 83 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
- Washington, DC, 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 (K990240) | Kay Elemetrics Corp. | 1999-03-11 |
| 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.