§ 882.5500. Lesion temperature monitor.
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/us/cfr/t21/s§ 882.5500·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A lesion temperature monitor is a device used to monitor the tissue temperature at the site where a lesion (tissue destruction) is to be made when a surgeon uses a radiofrequency
(RF)lesion generator and probe.
(b)Classification. Class II (performance standards).