1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 882 - NEUROLOGICAL DEVICES
  6. Subpart B - Neurological Diagnostic Devices
  7. 21 CFR § 882.1610
21 CFR § 882.1610
Alpha monitor
June 25, 2020
CFR

(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).

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

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