510(k) K060044

ACUTE CARE FACE MASK, MODEL RT040 by Fisher & Paykel Healthcare, Ltd. — Product Code MNT

K060044 is an FDA 510(k) premarket notification submitted by Fisher & Paykel Healthcare, Ltd. for the device "ACUTE CARE FACE MASK, MODEL RT040". The FDA issued a decision of Substantially Equivalent on April 6, 2006. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Fisher & Paykel Healthcare, Ltd. has at least 10 other 510(k) clearances on record.