21 CFR § 870.2340 Cardiovascular Devices

§ 870.2340 Electrocardiograph.

Current through Sep 8, 2026 · Read all of Part 870

⚠ 3 pending changes to Part 870

(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).

← § 870.2330 Echocardiograph.§ 870.2345 Electrocardiograph software for over-the-counter use. →