Device Classification Name |
image processing device for estimation of external blood loss
|
De Novo Number |
DEN130015 |
510(K) Number |
K130190
|
Device Name |
PIXEL 3 SYSTEM |
Requester |
gauss surgical, inc. |
334 state st., suite 201 |
los altos,
CA
94022
|
|
Contact |
peggy mclaughlin |
|
Regulation Number | 880.2750
|
Classification Product Code |
|
Date Received | 02/04/2013 |
Decision Date | 05/09/2014 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General Hospital
|
Review Advisory Committee |
General & Plastic Surgery
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|