510(k) K072450

ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 by Respironics California, Inc. — Product Code CBK

K072450 is an FDA 510(k) premarket notification submitted by Respironics California, Inc. for the device "ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000". The FDA issued a decision of Substantially Equivalent on December 12, 2007. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Respironics California, Inc. has at least 10 other 510(k) clearances on record.