Product code QSL
- Device name
- Brain Temperature Measurement System
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1565
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN200042 | BrainTemp Neonate System (BTNeo System) | Brain Temp, Inc. | 2022-03-29 |