510(k) K103214

M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130 by Lifeline Systems, Inc. — Product Code DRG

K103214 is an FDA 510(k) premarket notification submitted by Lifeline Systems, Inc. for the device "M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130". The FDA issued a decision of Substantially Equivalent on December 1, 2010. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Lifeline Systems, Inc. has at least 3 other 510(k) clearances on record.