| Device Classification Name |
System, Thermal Regulating
|
| 510(k) Number |
K904690 |
| Device Name |
TEMP MARQ(TM) CONVECTIVE WARMING SYSTEM |
| Applicant |
| Marquest Medical Products, Inc. |
| 11039 E. Lansing Cir. |
|
Englewood,
CO
80112
|
|
| Applicant Contact |
WARREN L BISBEE |
| Correspondent |
| Marquest Medical Products, Inc. |
| 11039 E. Lansing Cir. |
|
Englewood,
CO
80112
|
|
| Correspondent Contact |
WARREN L BISBEE |
| Regulation Number | 870.5900 |
| Classification Product Code |
|
| Date Received | 10/16/1990 |
| Decision Date | 02/01/1991 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|