510(k) K854158
- Device
- RESNICK EMITTER, ARTIFICIAL LARYNX
- Applicant
- DYNAMED AUDIO, INC.
- 510(k) number
- K854158
- Product code
- ESE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-12-13
- Date received
- 1985-10-11
- Regulation
- 874.3375
- Classification name
- Larynx, Artificial (battery-powered)
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSEPH A RESNICK
- Address
- R.D. 1 Box 415a Natrona Heights PA US 15065 15065
FDA Registration Numbers#
- 8032044
- 3016147813
- 2529591
- 3015259858
- 3006267333
- 3007615474
- 3043618799
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ESE #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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