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U.S. FDA Medical Device Battery-Powered Euthyscope Requirements


FDA Medical Device Definition: A euthyscope is a device that is a modified AC-powered or battery-powered ophthalmoscope (a perforated mirror device intended to inspect the interior of the eye) that projects a bright light encompassing an arc of about 30 degrees onto the fundus of the eye. The center of the light bundle is blocked by a black disk covering the fovea (the central depression of the macular retinae where only cones are present and blood vessels are lacking). The device is intended for use in the treatment of amblyopia (dimness of vision without apparent disease of the eye).

Registrar Corp assists Battery-Powered Euthyscope companies with:

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