510(k) K962638

TONOCAP, TC-200 AND ACCESSORY CATHETERS by Instrumentarium Corp. — Product Code CCK

K962638 is an FDA 510(k) premarket notification submitted by Instrumentarium Corp. for the device "TONOCAP, TC-200 AND ACCESSORY CATHETERS". The FDA issued a decision of Substantially Equivalent on April 4, 1997. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Instrumentarium Corp. has at least 10 other 510(k) clearances on record.