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.
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.
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