510(k) K963327

TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610 by Novametrix Medical Systems, Inc. — Product Code CCK

K963327 is an FDA 510(k) premarket notification submitted by Novametrix Medical Systems, Inc. for the device "TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610". The FDA issued a decision of Substantially Equivalent on November 20, 1996. 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.