Lesion temperature monitor.

21 C.F.R. § 882.5500
in effectEffective: 2024-07-01
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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).

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