510(k) K173060

F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version by Fisher and Paykel Healthcare Limited — Product Code CBK

K173060 is an FDA 510(k) premarket notification submitted by Fisher and Paykel Healthcare Limited for the device "F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version". The FDA issued a decision of Substantially Equivalent on January 25, 2018. The device falls under product code CBK (Ventilator, Continuous, Facility Use), a Class II device regulated under 21 CFR 868.5895. Fisher and Paykel Healthcare Limited has at least 10 other 510(k) clearances on record.