FDA Product Code
FDA Product Code ESE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3375
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K934483 | NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX | Mountain Precision Mfg. Ltd. Co. | 1994-03-16 | Traditional | PDF ↗ |
| K931371 | DENRICK SPEECH AID (DR-1) | Denrick Corp. | 1993-08-25 | Traditional | PDF ↗ |
| K923648 | LECTRO-LARYNX | Bruce Medical Supply | 1993-04-07 | Traditional | PDF ↗ |
| K914816 | AMERICAN ARTIFICIAL LARYNX | Ultravoice, Ltd. | 1993-02-12 | Traditional | PDF ↗ |
| K901503 | ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM | Stanton Magnetics, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K860992 | VOX COMPANION | Bloomfield Research and Development, Inc. | 1986-05-02 | Traditional | PDF ↗ |
| K860993 | P.O. VOX | Bloomfield Research and Development, Inc. | 1986-04-25 | Traditional | PDF ↗ |
| K854158 | RESNICK EMITTER, ARTIFICIAL LARYNX | Dynamed Audio, Inc. | 1985-12-13 | Traditional | PDF ↗ |
| K840892 | ELECTRO-PALATE | Cisko Systems | 1984-05-22 | Traditional | PDF ↗ |
| K834555 | BEAR VENTI--VOICE | Bear Medical Systems, Inc. | 1984-01-24 | Traditional | PDF ↗ |
| K834522 | VENTI-VOICE NASAL CATHETER | Respiratory Support Products, Inc. | 1984-01-17 | Traditional | PDF ↗ |
| K831127 | INTRA-ORAL ARTIFICIAL LARYNX | Xomed, Inc. | 1983-07-28 | Traditional | PDF ↗ |
| K823118 | SAY | Kells Medical, Inc. | 1983-01-07 | Traditional | PDF ↗ |
Product code ESE · Class I · Ear, Nose, Throat. Data: openFDA.