510(k) K122075

DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER by Intersurgical, Inc. — Product Code CCK

K122075 is an FDA 510(k) premarket notification submitted by Intersurgical, Inc. for the device "DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER". The FDA issued a decision of Substantially Equivalent on December 20, 2012. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Intersurgical, Inc. has at least 10 other 510(k) clearances on record.