Brain Temp, Inc.
Country not established
- Devices
- 1
What Brain Temp, Inc. makes
Brain Temp, Inc. manufactures the BrainTemp Neonate System, a device designed for monitoring brain temperature in neonatal patients to help prevent and manage hypothermia-related complications. The system is intended for use in neonatal intensive care units (NICUs) to provide continuous, accurate temperature readings in infants.
The BrainTemp Neonate System is classified as a Class II medical device under FDA regulations and has been authorised through the 510(k) clearance process. The company is based in the United States.
Catalogue
BrainTemp Neonate System (BTNeo System) Ref DEN200042
De Novo 510(k)
Frequently asked questions
How many devices does Brain Temp, Inc. have in the registry?
The registry currently lists 1 device for Brain Temp, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Brain Temp, Inc.'s devices?
Among its 1 most recently registered device, Brain Temp, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Brain Temp, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Brain Temp, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Brain Temp, Inc. in the registry?
The most recently registered devices listed for Brain Temp, Inc. include BrainTemp Neonate System (BTNeo System).