21 CFR 882.5500 — Monitor, Lesion Temperature
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5500
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.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GXT | Monitor, Lesion Temperature | 2 | 0 | 3rd Party |
