510(k) K023289

OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072 by Drager Medizintechnik GmbH — Product Code CBK

K023289 is an FDA 510(k) premarket notification submitted by Drager Medizintechnik GmbH for the device "OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072". The FDA issued a decision of Substantially Equivalent on January 15, 2003. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Drager Medizintechnik GmbH has at least 7 other 510(k) clearances on record.