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