Product code ESE
- Device name
- Larynx, Artificial (Battery-Powered)
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.3375
- 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 |
|---|---|---|---|
| K934483 | NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX | Mountain Precision Mfg. Ltd. Co. | 1994-03-16 |
| K931371 | DENRICK SPEECH AID (DR-1) | Denrick Corp. | 1993-08-25 |
| K923648 | LECTRO-LARYNX | Bruce Medical Supply | 1993-04-07 |
| K914816 | AMERICAN ARTIFICIAL LARYNX | Ultravoice, Ltd. | 1993-02-12 |
| K901503 | ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM | Stanton Magnetics, Inc. | 1990-06-28 |
| K860992 | VOX COMPANION | Bloomfield Research and Development, Inc. | 1986-05-02 |
| K860993 | P.O. VOX | Bloomfield Research and Development, Inc. | 1986-04-25 |
| K854158 | RESNICK EMITTER, ARTIFICIAL LARYNX | Dynamed Audio, Inc. | 1985-12-13 |
| K840892 | ELECTRO-PALATE | Cisko Systems | 1984-05-22 |
| K834555 | BEAR VENTI--VOICE | Bear Medical Systems, Inc. | 1984-01-24 |
| K834522 | VENTI-VOICE NASAL CATHETER | Respiratory Support Products, Inc. | 1984-01-17 |
| K831127 | INTRA-ORAL ARTIFICIAL LARYNX | Xomed, Inc. | 1983-07-28 |
| K823118 | SAY | Kells Medical, Inc. | 1983-01-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10850057368021 | Blom-Singer | Ent Solutions LLC | 2023-12-18 |
| 10850057368038 | Blom-Singer | Ent Solutions LLC | 2023-12-18 |
| 10850057368014 | Blom-Singer | Ent Solutions LLC | 2023-12-18 |
| 10850057368007 | Blom-Singer | Ent Solutions LLC | 2023-12-18 |
| 20850057368011 | Blom-Singer | Ent Solutions LLC | 2023-12-18 |
| 20850057368028 | Blom-Singer | Ent Solutions LLC | 2023-12-18 |
| 20850057368035 | Blom-Singer | Ent Solutions LLC | 2023-12-18 |
| 00860009460591 | Blom-Singer | Fountain Head Marketing Inc. | 2023-11-15 |
| 00860009460546 | Romet | Fountain Head Marketing Inc. | 2023-11-15 |
| 00860009460539 | Romet | Fountain Head Marketing Inc. | 2023-11-15 |
| 00860009460522 | Romet | Fountain Head Marketing Inc. | 2023-11-15 |
| 00860009460508 | Romet | Fountain Head Marketing Inc. | 2023-11-15 |
| 00860009460515 | Romet | Fountain Head Marketing Inc. | 2023-11-15 |
| 07331791015830 | Provox TruTone Emote | Atos Medical AB | 2022-07-08 |
| 07331791015571 | Provox TruTone Plus | Atos Medical AB | 2022-07-08 |
| 07331791015823 | Provox SolaTone Plus | Atos Medical AB | 2022-07-08 |
| 04040823006502 | SERVOX digital XL | Servona GmbH | 2021-02-18 |
| 00813124010981 | TruTone Plus® Electrolarynx | GRIFFIN LABORATORIES | 2021-02-05 |
| 00813124010738 | TruTone Plus® Electrolarynx | GRIFFIN LABORATORIES | 2020-08-24 |
| 00813124010974 | TruTone Plus® Electrolarynx | GRIFFIN LABORATORIES | 2020-08-24 |
| 00813124010868 | TeliTalk™ Electrolarynx | GRIFFIN LABORATORIES | 2020-03-17 |
| 00813124010875 | TeliTalk™ Electrolarynx | GRIFFIN LABORATORIES | 2020-03-17 |
| 00813124010004 | TruTone® Electrolarynx | GRIFFIN LABORATORIES | 2019-10-23 |
| 00813124010035 | SolaTone® Electrolarynx | GRIFFIN LABORATORIES | 2019-10-23 |
| 00813124010097 | TruTone® Electrolarynx | GRIFFIN LABORATORIES | 2019-10-23 |
| 00813124010103 | SolaTone Plus™ Electrolarynx | GRIFFIN LABORATORIES | 2019-10-23 |
| 00813124010110 | SolaTone Lite® Electrolarynx | GRIFFIN LABORATORIES | 2019-10-23 |
| 00813124010011 | TruTone® Electrolarynx | GRIFFIN LABORATORIES | 2019-07-23 |
| 00813124010356 | TruTone® Electrolarynx | GRIFFIN LABORATORIES | 2019-07-23 |
| 00848253003436 | InHealth Technologies; Blom-Singer | Freudenberg Medical, LLC | 2019-06-07 |