510(k) K050066

C-CO2 COLORIMETRIC CO2 INDICATOR by Marquest Medical Products, Inc. — Product Code CCK

K050066 is an FDA 510(k) premarket notification submitted by Marquest Medical Products, Inc. for the device "C-CO2 COLORIMETRIC CO2 INDICATOR". The FDA issued a decision of Substantially Equivalent on March 1, 2005. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Marquest Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2005
Date Received
January 12, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type