ESE — Larynx, Artificial (Battery-Powered) Class I
FDA product code ESE covers "Larynx, Artificial (Battery-Powered)", a Class I medical device regulated under 21 CFR 874.3375. Submissions are reviewed by the Ear, Nose, Throat panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ESE
- Device Class
- Class I
- Regulation Number
- 874.3375
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K934483 | mountain precision mfg. ltd | NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX | March 16, 1994 |
| K931371 | denrick | DENRICK SPEECH AID (DR-1) | August 25, 1993 |
| K923648 | bruce medical supply | LECTRO-LARYNX | April 7, 1993 |
| K914816 | ultravoice | AMERICAN ARTIFICIAL LARYNX | February 12, 1993 |
| K901503 | stanton magnetics | ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM | June 28, 1990 |
| K860992 | bloomfield research and development | VOX COMPANION | May 2, 1986 |
| K860993 | bloomfield research and development | P.O. VOX | April 25, 1986 |
| K854158 | dynamed audio | RESNICK EMITTER, ARTIFICIAL LARYNX | December 13, 1985 |
| K840892 | cisko systems | ELECTRO-PALATE | May 22, 1984 |
| K834555 | bear medical systems | BEAR VENTI--VOICE | January 24, 1984 |
| K834522 | respiratory support products | VENTI-VOICE NASAL CATHETER | January 17, 1984 |
| K831127 | xomed | INTRA-ORAL ARTIFICIAL LARYNX | July 28, 1983 |
| K823118 | kells medical | SAY | January 7, 1983 |