510(k) K041450

MODIFICATION TO NICO WITH MARS, MODEL 7300 by Respironics Novametrix, Inc. — Product Code CCK

K041450 is an FDA 510(k) premarket notification submitted by Respironics Novametrix, Inc. for the device "MODIFICATION TO NICO WITH MARS, MODEL 7300". The FDA issued a decision of Substantially Equivalent on June 18, 2004. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Respironics Novametrix, Inc. has at least 10 other 510(k) clearances on record.