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U.S. FDA Medical Device Operating-Room Table Requirements

FDA Medical Device Definition: A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

Registrar Corp assists Operating-Room Table companies with:

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