QSLClass II
Brain Temperature Measurement System
21 CFR 882.1565 / Neurology
QSL is the FDA product code for Brain Temperature Measurement System, a class II device type, regulated under 21 CFR 882.1565. FDA's definition for this code reads: "A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QSL
- Device name
- Brain Temperature Measurement System
- FDA definition
- A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature.
- Regulation
- 21 CFR 882.1565
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QSL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2022 | 1 |
Applicants with the most clearances
Product code QSL| Applicant | Clearances |
|---|---|
| Brain Temp, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QSL.
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