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U.S. FDA Medical Device Switching (Ploss) Valve Requirements


FDA Medical Device Definition: A switching valve (ploss) is a three-way valve located between a stethoscope placed over the heart, a blood pressure cuff, and an earpiece. The valve allows the user to eliminate one sound channel and listen only to a patient's heart or korotkoff (blood pressure) sounds through the other channel.

Registrar Corp assists Switching (Ploss) Valve companies with:

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