21 CFR § 882.1610 Neurological Devices

§ 882.1610 Alpha monitor.

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

⚠ 2 pending changes to Part 882

(a) Identification. An alpha monitor is a device with electrodes that are placed on a patient's scalp to monitor that portion of the electroencephalogram which is referred to as the alpha wave.

(b) Classification. Class II (performance standards).

← § 882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.§ 882.1620 Intracranial pressure monitoring device. →