510(k) DEN200042
DEN200042 is an FDA 510(k) premarket notification submitted by Brain Temp, Inc. for the device "BrainTemp Neonate System (BTNeo System)". The FDA issued a decision of De Novo Granted on March 29, 2022. The device falls under product code QSL (Brain Temperature Measurement System), a Class II device regulated under 21 CFR 882.1565.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 29, 2022
- Date Received
- June 23, 2020
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brain Temperature Measurement System
- Device Class
- Class II
- Regulation Number
- 882.1565
- Review Panel
- NE
- Submission Type
A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature.