Device Classification Name |
system, hemodialysis, access recirculation monitoring
|
510(k) Number |
K042566 |
Device Name |
VASC-ALERT |
Applicant |
VASC-ALERT, INC. |
1807 WEST SUNNYSIDE AVE. |
SUITE 301 |
CHICAGO,
IL
60640
|
|
Applicant Contact |
JOHN B KENNEDY |
Correspondent |
VASC-ALERT, INC. |
1807 WEST SUNNYSIDE AVE. |
SUITE 301 |
CHICAGO,
IL
60640
|
|
Correspondent Contact |
JOHN B KENNEDY |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 09/21/2004 |
Decision Date | 11/08/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|