Code of Federal Regulations · Section
§ 882.5500 — Lesion Temperature Monitor
21 C.F.R. § 882.5500
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(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).
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351