510(k) K843285

TRI-MED 610 CAPNOSTAT GAS ANALYZER by Tri-Med, Inc. — Product Code CCK

K843285 is an FDA 510(k) premarket notification submitted by Tri-Med, Inc. for the device "TRI-MED 610 CAPNOSTAT GAS ANALYZER". The FDA issued a decision of Substantially Equivalent on November 13, 1984. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Tri-Med, Inc. has at least 10 other 510(k) clearances on record.