510(k) K110594

GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS by Nihon Kohden Corp. — Product Code CCK

K110594 is an FDA 510(k) premarket notification submitted by Nihon Kohden Corp. for the device "GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS". The FDA issued a decision of Substantially Equivalent on October 28, 2011. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Nihon Kohden Corp. has at least 10 other 510(k) clearances on record.