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U.S. FDA Medical Device Adaptometer (Biophotometer) Requirements


FDA Medical Device Definition: An adaptometer (biophotometer) is an AC-powered device that provides a stimulating light source which has various controlled intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light threshold.

Registrar Corp assists Adaptometer (Biophotometer) companies with:

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