GLOTTAL FREQUENCY ANALYSER
FDA 510(k) clearance K841832 · decided 1984-07-18
Clearance details
- K-number
- K841832
- Device name
- GLOTTAL FREQUENCY ANALYSER
- Applicant
- Teltec Electronic Equipment AB
- Decision
- Substantially Equivalent
- Date received
- 1984-05-03
- Decision date
- 1984-07-18
- Days to decision
- 76 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
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Teltec Electronic Equipment AB
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| ELECTROGLOTTOGRAPH (K901609) | Glottal Ent., Inc. | 1990-06-28 |
| ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG (K821079) | Ms. Kate Teaney | 1982-05-10 |
Recalls involving this device
No recalls on record reference this clearance.