Code of Federal Regulations · Section

§ 882.1620 — Intracranial Pressure Monitoring Device

21 C.F.R. § 882.1620

View:

(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).

Authorizing Statute