| Device Classification Name |
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
|
| 510(k) Number |
K960972 |
| Device Name |
DISPOSABLE GAS SAMPLING INTERFACE KITS |
| Applicant |
| Marquest Medical Products, Inc. |
| 11039 E. Lansing Cir. |
|
Englewood,
CO
80112
|
|
| Applicant Contact |
TOM DIELMANN |
| Correspondent |
| Marquest Medical Products, Inc. |
| 11039 E. Lansing Cir. |
|
Englewood,
CO
80112
|
|
| Correspondent Contact |
TOM DIELMANN |
| Regulation Number | 868.1400 |
| Classification Product Code |
|
| Date Received | 03/11/1996 |
| Decision Date | 10/18/1996 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|