GXT — Monitor, Lesion Temperature Class II

FDA Device Classification

FDA product code GXT covers "Monitor, Lesion Temperature", a Class II medical device regulated under 21 CFR 882.5500. Submissions are reviewed by the Neurology panel.

Classification Details

Product Code
GXT
Device Class
Class II
Regulation Number
882.5500
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No