510(k) K843433
- Device
- KANIEVSKI SENSORY AID OR DEVICE
- Applicant
- SPECTRO INDUSTRIES, INC.
- 510(k) number
- K843433
- Product code
- LRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-11-14
- Date received
- 1984-09-04
- Regulation
- 510(k) Premarket Notification
- Classification name
- Hearing Aid, Tactile
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Ear Nose & Throat
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSEPH A GOLDBLUM
- Address
- Jenkintown Plz. Jenkintown PA US 19046 19046
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 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases