U.S. FDA Medical Device Intracranial Pressure Monitoring Device Requirements: Intracranial Pressure Monitoring Device
FDA Medical Device Definition: An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware
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U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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