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U.S. FDA Medical Device AC-Powered Pupillometer Requirements


FDA Medical Device Definition: A pupillometer is an AC-powered or manual device intended to measure by reflected light the width or diameter of the pupil of the eye.

Registrar Corp assists AC-Powered Pupillometer companies with:

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