Device Classification Name |
Controller, Temperature, Cardiopulmonary Bypass
|
510(k) Number |
K122813 |
Device Name |
HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM |
Applicant |
CINCINNATI SUB-ZERO PRODUCTS, INC. |
12011 MOSTELLER RD. |
CINCINNATI,
OH
45241
|
|
Applicant Contact |
STEVEN J BERKE |
Correspondent |
CINCINNATI SUB-ZERO PRODUCTS, INC. |
12011 MOSTELLER RD. |
CINCINNATI,
OH
45241
|
|
Correspondent Contact |
STEVEN J BERKE |
Regulation Number | 870.4250
|
Classification Product Code |
|
Date Received | 09/13/2012 |
Decision Date | 12/18/2012 |
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
|
|
|