Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 882 - NEUROLOGICAL DEVICES
/ Subpart F - Neurological Therapeutic Devices / § 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).