DeviceClearance

Product code QSL— Neurology

BrainTemp Neonate System (BTNeo System)

Classification name
Brain Temperature Measurement System
Device class
Class 2
Regulation
21 CFR 882.1565
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QSL under 21 CFR 882.1565, via openFDA

Market context for product code QSL

FDA has cleared 1 device under product code QSL, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QSL

Recent clearances under product code QSL

Data sourced from openFDA. This site is unofficial and independent of the FDA.