Chamber, Acoustic (For Audiometric Testing)
The acoustic chamber for audiometric testing is a sound-attenuating enclosure designed to reduce ambient noise levels to meet ANSI standards, providing a controlled acoustic environment for accurate audiometric test administration. It is classified as FDA Class 1, indicating minimal risk, subject only to general controls. The product code is EWC, regulated under 21 CFR 874.1060 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
- EWC
- Device Class
- FDA class 1
- Regulation Number
- 874.1060
- 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 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.