Device Classification Name |
monitor, blood-gas, on-line, cardiopulmonary bypass
|
510(k) Number |
K090147 |
Device Name |
BLOOD MONITORING UNIT, MODEL BMU 40 |
Applicant |
MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 |
HIRRLINGEN,
DE
72145
|
|
Applicant Contact |
ANASTASIA MUELLER |
Correspondent |
MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 |
HIRRLINGEN,
DE
72145
|
|
Correspondent Contact |
ANASTASIA MUELLER |
Regulation Number | 870.4330
|
Classification Product Code |
|
Date Received | 01/21/2009 |
Decision Date | 04/22/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|