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


FDA Medical Device Definition: A stereoscope is an AC-powered or battery-powered device that combines the images of two similar objects to produce a three-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle deviation), evaluate binocular vision (usage of both eyes to see), and guide a patient's corrective exercises of eye muscles.

Registrar Corp assists Battery-Powered Stereoscope companies with:

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