510(k) K010925

SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E by Siemens Elema AB — Product Code CBK

K010925 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E". The FDA issued a decision of Substantially Equivalent on December 18, 2001. 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.