21 C.F.R. § 882.5500

Current through October 31, 2024
Section 882.5500 - Lesion temperature monitor
(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).

21 C.F.R. §882.5500