QSL
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Brain Temperature Measurement System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1565
- Medical specialty
- Neurology
- FDA definition
- A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature.
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| Record | Firm | Date |
|---|---|---|
| BrainTemp Neonate System (BTNeo System) (DEN200042) | Brain Temp, Inc. | 2022-03-29 |
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