Device Classification Name |
intravascular bleed monitor
|
De Novo Number |
DEN180021 |
Device Name |
Early Bird Bleed Monitoring System |
Requester |
saranas, inc. |
2450 holcombe blvd. suite x |
houston,
TX
77021
|
|
Contact |
zaffer syed |
|
Regulation Number | 870.1345
|
Classification Product Code |
|
Date Received | 04/23/2018 |
Decision Date | 03/01/2019 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|