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U.S. FDA Medical Device Hydraulic Cystometric Device Requirements


FDA Medical Device Definition: A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.

Registrar Corp assists Hydraulic Cystometric Device companies with:

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