510(k) K211365

Alio Medical Remote Monitoring System by Graftworx, Inc. Dba Alio — Product Code DRG

K211365 is an FDA 510(k) premarket notification submitted by Graftworx, Inc. Dba Alio for the device "Alio Medical Remote Monitoring System". The FDA issued a decision of Substantially Equivalent on March 24, 2022. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910.