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.
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.
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