510(k) K243837

iBSM by Iorbit Digital Technologies Private Limited — Product Code DRG

K243837 is an FDA 510(k) premarket notification submitted by Iorbit Digital Technologies Private Limited for the device "iBSM". The FDA issued a decision of Substantially Equivalent on May 16, 2025. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910.