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U.S. FDA Medical Device Phonocardiograph Requirements

FDA Medical Device Definition: A phonocardiograph is a device used to amplify or condition the signal from a heart sound transducer. This device furnishes the excitation energy for the transducer and provides a visual or audible display of the heart sounds.

Registrar Corp assists Phonocardiograph companies with:

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