StacksVerified U.S. regulatory reference

21 CFR §882.1835

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (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).
  2. (b)Classification. Class II (performance standards).