510(k) K915494

NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60 by Nellcor, Inc. — Product Code CCK

K915494 is an FDA 510(k) premarket notification submitted by Nellcor, Inc. for the device "NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60". The FDA issued a decision of Substantially Equivalent on August 6, 1993. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Nellcor, Inc. has at least 10 other 510(k) clearances on record.