Device Classification Name |
System, Thermal Regulating
|
510(k) Number |
K121669 |
Device Name |
WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS) |
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 | 870.5900
|
Classification Product Code |
|
Date Received | 06/06/2012 |
Decision Date | 07/03/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|