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U.S. FDA Medical Device Diagnostic Ultrasonic Transducer Requirements: Diagnostic Ultrasonic Transducer

FDA Medical Device Definition: A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container

Registrar Corp assists Diagnostic Ultrasonic Transducer companies with:

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