510(k) K991086

CAPNOCHECK II, MODEL 8400 by Bci Intl., Inc. — Product Code CCK

K991086 is an FDA 510(k) premarket notification submitted by Bci Intl., Inc. for the device "CAPNOCHECK II, MODEL 8400". The FDA issued a decision of Substantially Equivalent on June 9, 1999. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Bci Intl., Inc. has at least 10 other 510(k) clearances on record.