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45 FR 7907, Feb. 5, 1980, unless otherwise noted.
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Nomenclature changes to part 870 appear at 73 FR 35341, June 23, 2008.
(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).