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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.

Registrar Corp assists Acoustic Chamber companies with:

  • FDA Acoustic Chamber Establishment Registration
  • FDA Acoustic Chamber Listing
  • 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.
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