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U.S. FDA Medical Device Opticokinetic Drum Requirements

FDA Medical Device Definition: An optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be rotated on its handle. The device is intended to elicit and evaluate nystagmus (involuntary rapid movement of the eyeball) in patients.

Registrar Corp assists Opticokinetic Drum companies with:

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