Device Classification Name |
ventilatory electrical impedance tomograph
|
De Novo Number |
DEN170072 |
Device Name |
Enlight 1810 |
Requester |
timpel inc. |
r. simao alvares |
356 cj.41-pinheiros |
sao paulo-sp,
BR
05417-020
|
|
Contact |
rafael holzhacker |
|
Regulation Number | 868.1505
|
Classification Product Code |
|
Date Received | 09/29/2017 |
Decision Date | 12/20/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Anesthesiology
|
Review Advisory Committee |
Anesthesiology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|