21 CFR 870.2350 - Electrocardiograph lead switching adaptor.
(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).