510(k) K813057
- Device
- VIBRO-COM COMMUNICATOR #8827
- Applicant
- SONIC SYSTEMS, INC.
- 510(k) number
- K813057
- Product code
- LRA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-12-02
- Date received
- 1981-10-29
- 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#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
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 |
| K830418 | TACTAID | Audiological Engineering Corp. | 1983-03-10 |
Legacy Summary#
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FDA Review#
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