Device Classification Name |
System, Thermal Regulating
|
510(k) Number |
K942599 |
Device Name |
WARM AIR WARMING UNIT |
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 | 06/01/1994 |
Decision Date | 01/24/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|