510(k) K130290

MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE by Intel-Ge Care Innovations, LLC — Product Code DRG

K130290 is an FDA 510(k) premarket notification submitted by Intel-Ge Care Innovations, LLC for the device "MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE". The FDA issued a decision of Substantially Equivalent on June 4, 2013. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Intel-Ge Care Innovations, LLC has at least 2 other 510(k) clearances on record.