510(k) K241101

BioButton System by Biointellisense, Inc. — Product Code DRG

K241101 is an FDA 510(k) premarket notification submitted by Biointellisense, Inc. for the device "BioButton System". The FDA issued a decision of Substantially Equivalent on September 26, 2024. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Biointellisense, Inc. has at least 1 other 510(k) clearance on record.