§ 870.1220. Electrode recording catheter or electrode recording probe.
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/us/cfr/t21/s§ 870.1220·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.
(b)Classification. Class II (performance standards).