510(k) K102985

V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS by Respironics, Inc. — Product Code MNT

K102985 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS". The FDA issued a decision of Substantially Equivalent on April 5, 2011. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Respironics, Inc. has at least 10 other 510(k) clearances on record.