510(k) K871354

SERVO VENTILATOR 900 C/D by Siemens Elema AB — Product Code CBK

K871354 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "SERVO VENTILATOR 900 C/D". The FDA issued a decision of Substantially Equivalent on July 21, 1987. 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.