Code of Federal Regulations · Section
§ 882.1835 — Physiological Signal Amplifier
21 C.F.R. § 882.1835
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(a) Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).
(b) Classification. Class II (performance standards).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351