Code of Federal Regulations · Section
§ 882.1610 — Alpha Monitor
21 C.F.R. § 882.1610
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(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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351