510(k) K960168

SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990 by Siemens Elema AB — Product Code CBK

K960168 is an FDA 510(k) premarket notification submitted by Siemens Elema AB for the device "SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990". The FDA issued a decision of ST on October 25, 1996. 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.