510(k) K130112

CAPNO MODULE, 92517 by Spacelabs Healthcare — Product Code CCK

K130112 is an FDA 510(k) premarket notification submitted by Spacelabs Healthcare for the device "CAPNO MODULE, 92517". The FDA issued a decision of Substantially Equivalent on March 21, 2013. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Spacelabs Healthcare has at least 10 other 510(k) clearances on record.