510(k) K221540

Synexis Sphere Rx by Synexis, LLC — Product Code FRA

K221540 is an FDA 510(k) premarket notification submitted by Synexis, LLC for the device "Synexis Sphere Rx". The FDA issued a decision of Substantially Equivalent on June 14, 2023. The device falls under product code FRA (Purifier, Air, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6500.