510(k) K980979

FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE by Fukuda Denshi USA, Inc. — Product Code CCK

K980979 is an FDA 510(k) premarket notification submitted by Fukuda Denshi USA, Inc. for the device "FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE". The FDA issued a decision of Substantially Equivalent on June 12, 1998. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Fukuda Denshi USA, Inc. has at least 10 other 510(k) clearances on record.