510(k) K910019

NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON by Novametrix Medical Systems, Inc. — Product Code CCK

K910019 is an FDA 510(k) premarket notification submitted by Novametrix Medical Systems, Inc. for the device "NOVAMETRIX MODEL 1265 END TIDAL CARBON DIOXIDE MON". The FDA issued a decision of Substantially Equivalent on March 26, 1991. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Novametrix Medical Systems, Inc. has at least 10 other 510(k) clearances on record.