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U.S. FDA Medical Device Audiometer Requirements

FDA Medical Device Definition: An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

Registrar Corp assists Audiometer companies with:

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