510(k) K941165

COMET CAPNOGRAPH MODULE by Spacelabs, Inc. — Product Code CCK

K941165 is an FDA 510(k) premarket notification submitted by Spacelabs, Inc. for the device "COMET CAPNOGRAPH MODULE". The FDA issued a decision of Substantially Equivalent on October 6, 1994. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Spacelabs, Inc. has at least 10 other 510(k) clearances on record.