21 CFR 874.1120 — Generator, Electronic Noise (For Audiometric Testing)
Ear, Nose, Throat (EN) · Part 874 Subpart B—Diagnostic Devices · § 874.1120
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ETS | Generator, Electronic Noise (For Audiometric Testing) | 2 | 5 |
Special Controls
ETS — Generator, Electronic Noise (For Audiometric Testing)
*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.
eCFR
