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U.S. FDA Medical Device Fetal Stethoscope Requirements

FDA Medical Device Definition: A fetal stethoscope is a device used for listening to fetal heart sounds. It is designed to transmit the fetal heart sounds not only through sound channels by air conduction, but also through the user's head by tissue conduction into the user's ears. It does not use ultrasonic energy. This device is designed to eliminate noise interference commonly caused by handling conventional stethoscopes.

Registrar Corp assists Fetal Stethoscope companies with:

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