510(k) DEN200042
- Device
- BrainTemp Neonate System (BTNeo System)
- Applicant
- Brain Temp, Inc.
- 510(k) number
- DEN200042
- Product code
- QSL
- Decision
- Unknown (DENG)
- Decision date
- 2022-03-29
- Date received
- 2020-06-23
- Regulation
- 882.1565
- Classification name
- Brain Temperature Measurement System
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- David Anderson
- Address
- P.O. Box 823 Bryn Mawr PA US 19010 19010
Source Documents
510(k) summary PDF not indicated by FDA