21 CFR 874.1060 — Chamber, Acoustic (For Audiometric Testing)
Ear, Nose, Throat (EN) · Part 874 Subpart B—Diagnostic Devices · § 874.1060
Identification
An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds.
Classification Rationale
Class I (general 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 |
|---|---|---|---|---|
| EWC | Chamber, Acoustic (For Audiometric Testing) | 1 | 2 |
