ETS · Generator, Electronic Noise (For Audiometric Testing)
Ear, Nose, Throat · 21 CFR 874.1120 · Class 2
Overview
| Product Code | ETS |
|---|---|
| Device Name | Generator, Electronic Noise (For Audiometric Testing) |
| Regulation | 21 CFR 874.1120 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K813557 | AUDITORY STIMULATOR | Western Advanced Technology, Inc. | Jan 19, 1982 | SESE |
| K811790 | OCTOTOXIC SCREENER | Western Advanced Technology, Inc. | Jul 15, 1981 | SESE |
| K811772 | AUDITORY LOCALIZER | Western Advanced Technology, Inc. | Jul 15, 1981 | SESE |
| K790064 | TINNITUS DEVICES | Vicon Instrument Co. | Feb 16, 1979 | SESE |
| K771188 | REVERSING CLICK GENERATOR RCG6 | Teca, Inc. | Jul 14, 1977 | SESE |
Top Applicants
- Western Advanced Technology, Inc. — 3 clearances
- Teca, Inc. — 1 clearance
- Vicon Instrument Co. — 1 clearance
