Tinnitus Devices
FDA 510(k) K790064 · Vicon Instrument Co.
510(k) numberK790064
Submission
- Device name
- Tinnitus Devices
- Applicant
- Vicon Instrument Co.
Mchenry, IL, US - Received
- January 15, 1979
- Decision date
- February 16, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ETS – Generator, Electronic Noise (For Audiometric Testing)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.1120
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ETS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K813557 | Auditory StimulatorETS · Traditional | Western Advanced Technology, Inc. | 01/19/1982SE |
| K811790 | Octotoxic ScreenerETS · Traditional | Western Advanced Technology, Inc. | 07/15/1981SE |
| K811772 | Auditory LocalizerETS · Traditional | Western Advanced Technology, Inc. | 07/15/1981SE |
| K771188 | Reversing Click Generator RCG6ETS · Traditional | Teca, Inc. | 07/14/1977SE |
More from Teca, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K811751 | Finetone Model Vi Hearing AidESD · Traditional | 07/15/1981SE |
| K790878 | Screening Audiometer, High FrequencyEWO · Traditional | 08/03/1979SE |
| K771769 | Tinnitus Maskers, Models S564&S574KLW · Traditional | 01/03/1978SE |
| K771762 | Modular Hearing Device, Model S291ESD · Traditional | 10/04/1977SE |
| K770938 | Tinnitus Aid, Model S244KLW · Traditional | 06/28/1977SE |
| K761216 | Hearing Aids (Model E-552 S-712)ESD · Traditional | 12/16/1976SE |
| K760215 | Hearing Aid, S-522 FMESD · Traditional | 07/21/1976SE |
Questions and answers
When was Tinnitus Devices cleared by the FDA?
Tinnitus Devices (K790064) received a 510(k) decision of Substantially Equivalent on February 16, 1979, 32 days after the submission was received.
What is the product code of K790064?
The FDA product code is ETS – Generator, Electronic Noise (For Audiometric Testing), a Class II (moderate risk) device regulated under 21 CFR 874.1120.