StacksVerified U.S. regulatory reference

21 CFR §870.2340

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.
  2. (b)Classification. Class II (performance standards).