Device Classification Name |
software device to aid in the prediction or diagnosis of sepsis
|
De Novo Number |
DEN230036 |
Device Name |
Sepsis ImmunoScore |
Requester |
prenosis, inc. |
3440 s dearborn street |
suite 222s |
chicago,
IL
60616
|
|
Contact |
bobby reddy |
|
Regulation Number | 880.6316
|
Classification Product Code |
|
Date Received | 05/05/2023 |
Decision Date | 04/02/2024 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General Hospital
|
Review Advisory Committee |
Gastroenterology/Urology
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|