BrainTemp Neonate System (BTNeo System)— 510(k) DEN200042
UnknownBrain Temp, Inc.
FDA 510(k) clearance DEN200042 for BrainTemp Neonate System (BTNeo System), Unknown on 2022-03-29. Applicant: Brain Temp, Inc.. Device class: 2.
Clearance details
- Applicant
- Brain Temp, Inc.
- Product code
- Code QSL
- Device class
- Class 2
- Regulation
- 21 CFR 882.1565
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Bryn Mawr, PA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.