Device Classification Name |
brain temperature measurement system
|
De Novo Number |
DEN200042 |
Device Name |
BrainTemp Neonate System (BTNeo System) |
Requester |
brain temp inc. |
p.o box 823 |
bryn mawr,
PA
19010
|
|
Contact |
david anderson |
|
Regulation Number | 882.1565
|
Classification Product Code |
|
Date Received | 06/23/2020 |
Decision Date | 03/29/2022 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|