510(k) K041412

ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 by Respironics California, Inc. — Product Code CBK

K041412 is an FDA 510(k) premarket notification submitted by Respironics California, Inc. for the device "ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000". The FDA issued a decision of Substantially Equivalent on June 18, 2004. 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.