21 CFR § 882.1620 Neurological Devices

§ 882.1620 Intracranial pressure monitoring device.

Current through Sep 8, 2026 · Read all of Part 882

⚠ 2 pending changes to Part 882

(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).

← § 882.1610 Alpha monitor.§ 882.1630 Cranial motion measurement device. →