510(k) K914889

GEMSCOM SERIES 3000 by General Devices — Product Code DRG

K914889 is an FDA 510(k) premarket notification submitted by General Devices for the device "GEMSCOM SERIES 3000". The FDA issued a decision of Substantially Equivalent on March 4, 1992. 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.