The following data is part of a premarket notification filed by Marquest Medical Products, Inc. with the FDA for C-co2 Colorimetric Co2 Indicator.
| Device ID | K050066 |
| 510k Number | K050066 |
| Device Name: | C-CO2 COLORIMETRIC CO2 INDICATOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Contact | Thomas W Dielmann |
| Correspondent | Thomas W Dielmann MARQUEST MEDICAL PRODUCTS, INC. 11039 EAST LANSING CIR. Englewood, CO 80112 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-12 |
| Decision Date | 2005-03-01 |
| Summary: | summary |