StacksVerified U.S. regulatory reference

21 CFR §882.1620

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (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.
  2. (b)Classification. Class II (performance standards).