Generator, Electronic Noise (For Audiometric Testing)
The electronic noise generator for audiometric testing is a device that produces calibrated masking noise used during audiometric evaluations to prevent the non-test ear from responding to test stimuli, ensuring accurate hearing threshold measurements. It is classified as FDA Class 2, indicating moderate risk, and is subject to special controls without requiring a traditional 510(k) for all configurations. The product code is ETS, regulated under 21 CFR 874.1120 in the Ear, Nose, Throat specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
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Basic Information
- Product Code
- ETS
- Device Class
- FDA class 2
- Regulation Number
- 874.1120
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K813557 | AUDITORY STIMULATOR | Jan 19, 1982 | Substantially Equivalent | Western Advanced Technology, Inc. |
| K811790 | OCTOTOXIC SCREENER | Jul 15, 1981 | Substantially Equivalent | Western Advanced Technology, Inc. |
| K811772 | AUDITORY LOCALIZER | Jul 15, 1981 | Substantially Equivalent | Western Advanced Technology, Inc. |
| K790064 | TINNITUS DEVICES | Feb 16, 1979 | Substantially Equivalent | Vicon Instrument Co. |
| K771188 | REVERSING CLICK GENERATOR RCG6 | Jul 14, 1977 | Substantially Equivalent | Teca, Inc. |