510(k) K191624

F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version by Fisher & Paykel Healthcare Limited — Product Code MNT

K191624 is an FDA 510(k) premarket notification submitted by Fisher & Paykel Healthcare Limited for the device "F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version". The FDA issued a decision of Substantially Equivalent on March 9, 2020. The device falls under product code MNT (Sv70 Ventilator), a Class II device regulated under 21 CFR 868.5895. Fisher & Paykel Healthcare Limited has at least 10 other 510(k) clearances on record.