510(k) K851441
- Device
- Tacticon 1600
- Applicant
- MEDECON
- 510(k) number
- K851441
- Product code
- LRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-06-27
- Date received
- 1985-04-10
- Classification name
- Hearing Aid, Tactile
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- EARLE L CANTY
- Address
- 21906 Hyannisport Cupertino CA US 95014 95014
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LRA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883853 | ETA | Sevrain-Tech, Inc. | 1988-11-17 |
| K862471 | WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER | Institute of Logopedics | 1986-09-12 |
| K851655 | TEACHER TM | Monargue Intl. | 1985-06-20 |
| K843433 | KANIEVSKI SENSORY AID OR DEVICE | Spectro Industries, Inc. | 1984-11-14 |
| K831501 | TACTIL EAR | Ear Three Systems | 1983-08-26 |
| K830418 | TACTAID | Audiological Engineering Corp. | 1983-03-10 |
| K813057 | VIBRO-COM COMMUNICATOR #8827 | Sonic Systems, Inc. | 1981-12-02 |