21 C.F.R. § 870.2340
Electrocardiograph.
Cite as 21 C.F.R. § 870.2340 (2026)
(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. (b) Classification. Class II (performance standards).