Registrar Corp

HomeMedical Devices510(k) Administrative ReviewMedical Device 510(k) Examples › U.S. FDA Automated External Defibrillator Regulations

U.S. FDA Medical Device Automated External Defibrillator Requirements: Automated External Defibrillator

FDA Medical Device Definition: An automated external defibrillator (AED) is a low-energy device with a rhythm recognition detection system that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart. An AED analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia

Registrar Corp assists Automated External Defibrillator companies with:

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