21 C.F.R. § 882.1620
Intracranial pressure monitoring device.
Cite as 21 C.F.R. § 882.1620 (2026)
(a)
Identification.
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.
(b)
Classification.
Class II (performance standards).