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U.S. FDA Medical Device Anomaloscope Requirements

FDA Medical Device Definition: An anomaloscope is an AC-powered device intended to test for anomalies of color vision by displaying mixed spectral lines to be matched by the patient.

Registrar Corp assists Anomaloscope companies with:

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