510(k) K240251

ANNE Chest by Sibel Health, Inc. — Product Code DRG

K240251 is an FDA 510(k) premarket notification submitted by Sibel Health, Inc. for the device "ANNE Chest". The FDA issued a decision of Substantially Equivalent on June 3, 2024. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Sibel Health, Inc. has at least 4 other 510(k) clearances on record.