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U.S. FDA Medical Device Signal Isolation System Requirements


FDA Medical Device Definition: A signal isolation system is a device that electrically isolates the patient from equipment connected to the commercial power supply received from a utility company. This isolation may be accomplished, for example, by transformer coupling, acoustic coupling, or optical coupling.

Registrar Corp assists Signal Isolation System companies with:

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