510(k) K800869

MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA by Cavitron Corp. — Product Code CCK

K800869 is an FDA 510(k) premarket notification submitted by Cavitron Corp. for the device "MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA". The FDA issued a decision of Substantially Equivalent on May 28, 1980. The device falls under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1400. Cavitron Corp. has at least 10 other 510(k) clearances on record.