FDA product code QSL: Brain Temperature Measurement System
QSL is the FDA product code for brain temperature measurement system. It is a Class II device, regulated under 21 CFR 882.1565 and reviewed by the Neurology panel. Devices under QSL reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature.
Classification
| Field | Value |
|---|---|
| Device name | Brain Temperature Measurement System |
| Device class | Class II |
| Regulation | 21 CFR 882.1565 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for QSL devices
openFDA lists no recalls for product code QSL.
Frequently asked questions
What is FDA product code QSL?
QSL is the FDA product code for brain temperature measurement system. It is a Class II device, regulated under 21 CFR 882.1565 and reviewed by the Neurology panel.
What device class is QSL?
Class II, regulation 21 CFR 882.1565. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QSL
- Run a recall and safety report across every QSL manufacturer
- Watch product code QSL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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