U.S. FDA Medical Device Acoustic Chamber Requirements
FDA Medical Device Definition: 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.
FDA Acoustic Chamber Label Requirements and Exceptions
FDA Acoustic Chamber Import Information
FDA Acoustic Chamber Detentions (Acoustic Chamber Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Acoustic Chamber Manufacturers (Acoustic Chamber Suppliers)
- Acoustic Chamber Distributors
- Acoustic Chamber Processors
- Acoustic Chamber Repackers
- Acoustic Chamber Relabelers
- Acoustic Chamber Exporters
- Acoustic Chamber Importers
For more information about Acoustic Chamber Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.