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


FDA Medical Device Definition: A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.

Registrar Corp assists Battery-Powered Keratoscope companies with:

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