21 CFR § 870.2350 Cardiovascular Devices

§ 870.2350 Electrocardiograph lead switching adaptor.

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

⚠ 3 pending changes to Part 870

(a) Identification. An electrocardiograph lead switching adaptor is a passive switching device to which electrocardiograph limb and chest leads may be attached. This device is used to connect various combinations of limb and chest leads to the output terminals in order to create standard lead combinations such as leads I, II, and III.

(b) Classification. Class II (performance standards).

← § 870.2345 Electrocardiograph software for over-the-counter use.§ 870.2360 Electrocardiograph electrode. →