510(k) K002089

ROSETTA-LT/ROSETTA-RX by General Devices — Product Code DRG

K002089 is an FDA 510(k) premarket notification submitted by General Devices for the device "ROSETTA-LT/ROSETTA-RX". The FDA issued a decision of Substantially Equivalent on November 21, 2000. 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.