510(k) K071212

ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 by Respironics California, Inc. — Product Code CBK

K071212 is an FDA 510(k) premarket notification submitted by Respironics California, Inc. for the device "ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000". The FDA issued a decision of Substantially Equivalent on July 30, 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.