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U.S. FDA Medical Device External Negative Pressure Ventilator Requirements: External Negative Pressure Ventilator

FDA Medical Device Definition: An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient

Registrar Corp assists External Negative Pressure Ventilator companies with:

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




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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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