510(k) K211560

Airvo Nebulizer Adapter by Fisher & Paykel Healthcare Limited — Product Code CAF

K211560 is an FDA 510(k) premarket notification submitted by Fisher & Paykel Healthcare Limited for the device "Airvo Nebulizer Adapter". The FDA issued a decision of Substantially Equivalent on December 10, 2021. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Fisher & Paykel Healthcare Limited has at least 10 other 510(k) clearances on record.