510(k) K082660

V60 VENTILATOR, MODEL V8000 by Respironics California, Inc. — Product Code MNT

K082660 is an FDA 510(k) premarket notification submitted by Respironics California, Inc. for the device "V60 VENTILATOR, MODEL V8000". The FDA issued a decision of Substantially Equivalent on January 9, 2009. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Respironics California, Inc. has at least 10 other 510(k) clearances on record.