Device Classification Name |
image processing device for estimation of external blood loss
|
510(k) Number |
K142801 |
Device Name |
Triton Canister System |
Applicant |
Gauss Surgical, Inc. |
334 State Street, Suite 201 |
los altos,
CA
94022
|
|
Applicant Contact |
peggy mclaughlin |
Correspondent |
Gauss Surgical, Inc. |
334 State Street, Suite 201 |
los altos,
CA
94022
|
|
Correspondent Contact |
peggy mclaughlin |
Regulation Number | 880.2750
|
Classification Product Code |
|
Date Received | 09/29/2014 |
Decision Date | 03/12/2015 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|