CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 882—NEUROLOGICAL DEVICES > SUBPART F—Neurological Therapeutic Devices (§882.5030 to §882.5975) > 882.5500—Lesion temperature monitor.

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).