Device Classification Name |
adjunctive cardiovascular status indicator
|
De Novo Number |
DEN160020 |
Device Name |
CipherOx CRI Tablet |
Requester |
flashback technologies, inc. |
1215 spruce street, suite 101 |
boulder,
CO
80302
|
|
Contact |
gordon van dusen |
|
Regulation Number | 870.2200
|
Classification Product Code |
|
Date Received | 05/24/2016 |
Decision Date | 12/21/2016 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|