510(k) K202480

Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 by Parker Hannifin — Product Code BZR

K202480 is an FDA 510(k) premarket notification submitted by Parker Hannifin for the device "Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50". The FDA issued a decision of Substantially Equivalent on April 22, 2021. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Parker Hannifin has at least 8 other 510(k) clearances on record.