510(k) K051262

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

K051262 is an FDA 510(k) premarket notification submitted by Respironics California, Inc. for the device "ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000". The FDA issued a decision of Substantially Equivalent on July 8, 2005. 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.