QSL · Class II · 21 CFR 882.1565

FDA Product Code QSL: Brain Temperature Measurement System

A Brain Temperature Measurement System Is An Externally Placed, Prescription Device Intended To Measure Brain Temperature.

Leading manufacturers include Brain Temp, Inc..

1
Total
0
Cleared
644d
Avg days
2022
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Brain Temperature Measurement System Devices (Product Code QSL)

1 devices
1–1 of 1

About Product Code QSL - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QSL since 2022, with 0 receiving FDA clearance (average review time: 644 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.

QSL devices are reviewed by the Neurology panel. Browse all Neurology devices →