510(k) K935839

GEMSCOM SERIES 5000, by General Devices — Product Code DRG

K935839 is an FDA 510(k) premarket notification submitted by General Devices for the device "GEMSCOM SERIES 5000,". The FDA issued a decision of Substantially Equivalent on November 10, 1994. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. General Devices has at least 10 other 510(k) clearances on record.