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
-
Adulterated drugs and devices21 U.S.C. § 351