510(k) K830418
- Device
- Tactaid
- Applicant
- AUDIOLOGICAL ENGINEERING CORP.
- 510(k) number
- K830418
- Product code
- LRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-10
- Date received
- 1983-02-08
- Classification name
- Hearing Aid, Tactile
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- MD US
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 |
| K851441 | TACTICON 1600 | Medecon | 1985-06-27 |
| 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 |
| K813057 | VIBRO-COM COMMUNICATOR #8827 | Sonic Systems, Inc. | 1981-12-02 |