Registrar Corp

HomeMedical Devices510(k) Administrative ReviewMedical Device 510(k) Examples › U.S. FDA Electrohydraulic Lithotriptor Regulations

U.S. FDA Medical Device Electrohydraulic Lithotriptor Requirements: Electrohydraulic Lithotriptor

FDA Medical Device Definition: An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone

Registrar Corp assists Electrohydraulic Lithotriptor companies with:

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




Live Help

 
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.
Home | About Us | News | Resources | Exhibitions | Seminars | Associations | Careers | Sitemap | Terms of Use © 2016 Registrar Corp
 
Food and Beverages | Drugs | Cosmetics | Medical Devices | Radiation-Emitting Electronic Devices | Color Additives | Tobacco