Device Classification Name |
analyzer, gas, carbon-dioxide, gaseous-phase
|
510(k) Number |
K050066 |
Device Name |
C-CO2 COLORIMETRIC CO2 INDICATOR |
Applicant |
MARQUEST MEDICAL PRODUCTS, INC. |
11039 EAST LANSING CIR. |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
THOMAS W DIELMANN |
Correspondent |
MARQUEST MEDICAL PRODUCTS, INC. |
11039 EAST LANSING CIR. |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
THOMAS W DIELMANN |
Regulation Number | 868.1400
|
Classification Product Code |
|
Date Received | 01/12/2005 |
Decision Date | 03/01/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|