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U.S. FDA Medical Device Target Tangent Screen Requirements

FDA Medical Device Definition: A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square cloth chart with a central mark of fixation intended to map on a flat surface the central 30 degrees of a patient's visual field. This generic type of device includes projection tangent screens, target tangent screens and targets, felt tangent screens, and stereo campimeters.

Registrar Corp assists Target Tangent Screen companies with:

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