510(k) K211305

ANNE One by Sibel, Inc. — Product Code DRG

K211305 is an FDA 510(k) premarket notification submitted by Sibel, Inc. for the device "ANNE One". The FDA issued a decision of Substantially Equivalent on September 14, 2021. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Sibel, Inc. has at least 2 other 510(k) clearances on record.