Device Classification Name |
computer, diagnostic, pre-programmed, single-function
|
510(k) Number |
K122400 |
Device Name |
CARDIOX FLOW DETECTION SYSTEM |
Applicant |
CARDIOX CORP. |
4100 HORIZONS DRIVE, SUITE 100 |
COLUMBUS,
OH
43220
|
|
Applicant Contact |
KAREN MATIS |
Correspondent |
CARDIOX CORP. |
4100 HORIZONS DRIVE, SUITE 100 |
COLUMBUS,
OH
43220
|
|
Correspondent Contact |
KAREN MATIS |
Regulation Number | 870.1435
|
Classification Product Code |
|
Date Received | 08/07/2012 |
Decision Date | 11/05/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|