510(k) K861707

MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR by Siemens Elema AB — Product Code CBK

K861707 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR". The FDA issued a decision of Substantially Equivalent on June 19, 1986. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Siemens Elema AB has at least 10 other 510(k) clearances on record.