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U.S. FDA Medical Device Earphone Cushion Requirements

FDA Medical Device Definition: An earphone cushion for audiometric testing is a device that is used to cover an audiometer earphone during audiometric testing to provide an acoustic coupling (sound connection path) between the audiometer earphone and the patient's ear.

Registrar Corp assists Earphone Cushion companies with:

  • FDA Earphone Cushion Establishment Registration
  • FDA Earphone Cushion Listing
  • FDA Earphone Cushion Label Requirements and Exceptions
  • FDA Earphone Cushion Import Information
  • FDA Earphone Cushion Detentions (Earphone Cushion Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Earphone Cushion Manufacturers (Earphone Cushion Suppliers)
       - Earphone Cushion Distributors
       - Earphone Cushion Processors
       - Earphone Cushion Repackers
       - Earphone Cushion Relabelers
       - Earphone Cushion Exporters
       - Earphone Cushion Importers
For more information about Earphone Cushion 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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