QSL

Brain Temperature Measurement System

Product code: QSL
Device name: Brain Temperature Measurement System
Device class: Class 2
21 CFR: 21 CFR 882.1565
Medical specialty: Neurology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 1 (all years; only the last 3 years are listed here)

FDA classification definition

A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QSL

Classification and pathway per current FDA publications. Data from openFDA (CC0).