QSL — Brain Temperature Measurement System Class II
FDA product code QSL covers "Brain Temperature Measurement System", a Class II medical device regulated under 21 CFR 882.1565. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QSL
- Device Class
- Class II
- Regulation Number
- 882.1565
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN200042 | brain temp | BrainTemp Neonate System (BTNeo System) | March 29, 2022 |