510(k) K161487

VPAP Adapt SV, VPAP Tx, S9 VPAP Tx by Resmed, Ltd. — Product Code MNS

K161487 is an FDA 510(k) premarket notification submitted by Resmed, Ltd. for the device "VPAP Adapt SV, VPAP Tx, S9 VPAP Tx". The FDA issued a decision of Substantially Equivalent on September 9, 2016. The device falls under product code MNS (Ventilator, Continuous, Non-Life-Supporting), a Class II device regulated under 21 CFR 868.5895. Resmed, Ltd. has at least 10 other 510(k) clearances on record.