510(k) K031741

MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 by Alaris Medical Systems, Inc. — Product Code CCK

K031741 is an FDA 510(k) premarket notification submitted by Alaris Medical Systems, Inc. for the device "MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300". The FDA issued a decision of Substantially Equivalent on February 9, 2004. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Alaris Medical Systems, Inc. has at least 10 other 510(k) clearances on record.