Device Classification Name |
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
|
510(k) Number |
K133658 |
Device Name |
CDI BLOOD PARAMETER MONITORING SYSTEM 500 |
Applicant |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103
|
|
Applicant Contact |
Kevin Kong |
Correspondent |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103
|
|
Correspondent Contact |
Kevin Kong |
Regulation Number | 870.4330
|
Classification Product Code |
|
Date Received | 11/27/2013 |
Decision Date | 07/25/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|