← Product Code [ETS](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETS) · K790064

# TINNITUS DEVICES (K790064)

_Vicon Instrument Co. · ETS · Feb 16, 1979 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETS/K790064

## Device Facts

- **Applicant:** Vicon Instrument Co.
- **Product Code:** [ETS](/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETS.md)
- **Decision Date:** Feb 16, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.1120
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An electronic noise generator for audiometric testing is a device that consists of a swept frequency generator, an amplifier, and an earphone. It is intended to introduce a masking noise into the non-test ear during an audiometric evaluation. The device minimizes the non-test ear's sensing of test tones and signals being generated for the ear being tested.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETS/K790064](https://fda.innolitics.com/submissions/EN/subpart-b%E2%80%94diagnostic-devices/ETS/K790064)

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