510(k) K940009

GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 by General Devices — Product Code DRG

K940009 is an FDA 510(k) premarket notification submitted by General Devices for the device "GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300". The FDA issued a decision of Substantially Equivalent on April 14, 1995. 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.