RESNICK EMITTER, ARTIFICIAL LARYNX
FDA 510(k) clearance K854158 · decided 1985-12-13
Clearance details
- K-number
- K854158
- Device name
- RESNICK EMITTER, ARTIFICIAL LARYNX
- Applicant
- Dynamed Audio, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-10-11
- Decision date
- 1985-12-13
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- ESE
- Device class
- 1
- Regulation number
- 874.3375
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Natrona Heights, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX (K934483) | Mountain Precision Mfg. Ltd. Co. | 1994-03-16 |
| DENRICK SPEECH AID (DR-1) (K931371) | Denrick Corp. | 1993-08-25 |
| LECTRO-LARYNX (K923648) | Bruce Medical Supply | 1993-04-07 |
| AMERICAN ARTIFICIAL LARYNX (K914816) | Ultravoice, Ltd. | 1993-02-12 |
| ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM (K901503) | Stanton Magnetics, Inc. | 1990-06-28 |
| VOX COMPANION (K860992) | Bloomfield Research and Development, Inc. | 1986-05-02 |
| P.O. VOX (K860993) | Bloomfield Research and Development, Inc. | 1986-04-25 |
| ELECTRO-PALATE (K840892) | Cisko Systems | 1984-05-22 |
| BEAR VENTI--VOICE (K834555) | Bear Medical Systems, Inc. | 1984-01-24 |
| VENTI-VOICE NASAL CATHETER (K834522) | Respiratory Support Products, Inc. | 1984-01-17 |
| INTRA-ORAL ARTIFICIAL LARYNX (K831127) | Xomed, Inc. | 1983-07-28 |
| SAY (K823118) | Kells Medical, Inc. | 1983-01-07 |
Recalls involving this device
No recalls on record reference this clearance.