Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K140177 |
Device Name |
MEDOS HILITE OXYGENATOR |
Applicant |
MEDOS MEDIZINTECHNIK AG |
3526 WEST LIBERTY RD. |
ANN ARBOR,
MI
48103
|
|
Applicant Contact |
Leann Christman |
Correspondent |
MEDOS MEDIZINTECHNIK AG |
3526 WEST LIBERTY RD. |
ANN ARBOR,
MI
48103
|
|
Correspondent Contact |
Leann Christman |
Regulation Number | 870.4350
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/24/2014 |
Decision Date | 02/18/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|