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U.S. FDA Medical Device Artificial Larynx Requirements

FDA Medical Device Definition: A battery-powered artificial larynx is an externally applied device intended for use in the absence of the larynx to produce sound. When held against the skin in the area of the voicebox, the device generates mechanical vibrations which resonate in the oral and nasal cavities and can be modulated by the tongue and lips in a normal manner, thereby allowing the production of speech.

Registrar Corp assists Artificial Larynx companies with:

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