Product code KLX
- Device name
- Electroglottograph
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.1325
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K990240 | ELECTROGLOTTOGRAPH | Kay Elemetrics Corp. | 1999-03-11 |
| K901609 | ELECTROGLOTTOGRAPH | Glottal Ent., Inc. | 1990-06-28 |
| K841832 | GLOTTAL FREQUENCY ANALYSER | Teltec Electronic Equipment AB | 1984-07-18 |
| K821079 | ELECTROGLOTTOGRAPH NAKED EGG BOXED EGG | Ms. Kate Teaney | 1982-05-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04961333255986 | Disposables Kit | PENTAX OF AMERICA, INC. | 2025-07-21 |
| 04961333255979 | MICROPHONE ASSAY KIT | PENTAX OF AMERICA, INC. | 2025-07-21 |
| 00860011116905 | Two Channel Electroglottograph EG2-PCX2 | Glottal Enterprises, Inc. | 2024-07-01 |
| 04961333254309 | MULTI-SPEECH | PENTAX OF AMERICA, INC. | 2023-08-25 |
| 04961333247301 | NASOMETER | PENTAX OF AMERICA, INC. | 2019-06-07 |
| 04961333247318 | NASOMETER | PENTAX OF AMERICA, INC. | 2019-06-07 |
| 04961333247417 | PHONATORY AERODYNAMIC SYSTEM (SOFTWARE) | PENTAX OF AMERICA, INC. | 2019-06-07 |
| 04961333247424 | PHONATORY AERODYNAMIC SYSTEM | PENTAX OF AMERICA, INC. | 2019-06-07 |
| 04961333229741 | MDVP | PENTAX OF AMERICA, INC. | 2017-04-06 |
| 04961333229833 | N/A | PENTAX OF AMERICA, INC. | 2017-04-06 |
| 04961333229758 | ADSV | PENTAX OF AMERICA, INC. | 2017-04-06 |
| 04961333229765 | REAL-TIME | PENTAX OF AMERICA, INC. | 2017-04-06 |
| 04961333229772 | SONA-MATCH | PENTAX OF AMERICA, INC. | 2017-04-06 |
| 04961333229789 | REAL-TIME | PENTAX OF AMERICA, INC. | 2017-04-06 |
| 04961333229796 | REAL-TIME | PENTAX OF AMERICA, INC. | 2017-04-06 |
| 04961333229802 | N/A | PENTAX OF AMERICA, INC. | 2017-04-06 |
| 04961333229819 | N/A | PENTAX OF AMERICA, INC. | 2017-04-06 |
| 04961333229826 | N/A | PENTAX OF AMERICA, INC. | 2017-04-06 |
| 04961333229727 | N/A | PENTAX OF AMERICA, INC. | 2017-04-05 |
| 04961333229734 | ASL | PENTAX OF AMERICA, INC. | 2017-04-05 |
| 04961333229710 | N/A | PENTAX OF AMERICA, INC. | 2017-04-05 |
| 04961333229703 | N/A | PENTAX OF AMERICA, INC. | 2017-04-05 |
| 04961333229697 | N/A | PENTAX OF AMERICA, INC. | 2017-04-05 |
| 04961333229680 | N/A | PENTAX OF AMERICA, INC. | 2017-04-05 |
| 04961333229673 | VRP | PENTAX OF AMERICA, INC. | 2017-04-05 |
| 04961333229666 | N/A | PENTAX OF AMERICA, INC. | 2017-04-05 |
| 04961333229659 | MULTI-SPEECH | PENTAX OF AMERICA, INC. | 2017-04-05 |
| 04961333229642 | MULTI-SPEECH | PENTAX OF AMERICA, INC. | 2017-04-05 |
| 04961333229635 | SONA-SPEECH II | PENTAX OF AMERICA, INC. | 2017-04-05 |
| 04961333229628 | N/A | PENTAX OF AMERICA, INC. | 2017-04-05 |