Device Classification Name |
display, cathode-ray tube, medical
|
510(k) Number |
K131272 |
Device Name |
SIREN EPCR SUITE |
Applicant |
MEDUSA MEDICAL TECHNOLOGIES INC. |
816 CONGRESS AVE. |
SUITE 1400 |
AUSTIN,
TX
78701
|
|
Applicant Contact |
DIANE SUDDUTH |
Correspondent |
MEDUSA MEDICAL TECHNOLOGIES INC. |
816 CONGRESS AVE. |
SUITE 1400 |
AUSTIN,
TX
78701
|
|
Correspondent Contact |
DIANE SUDDUTH |
Regulation Number | 870.2450
|
Classification Product Code |
|
Date Received | 05/03/2013 |
Decision Date | 01/03/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|