21 CFR 882.5500

§ 882.5500 Lesion temperature monitor.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 882.5500, § 882.5500 Lesion temperature monitor, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90729
Permanent ID: ys:prov:90729@1
SHA-256: 70cd281f8a8a3ef8185f0339a3b9a296577e6bbc12ea9813323fa91a1a53ffcc

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Full text

(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).

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.