510(k) K091696

SAVI WIRELESS, MODEL PM500 by Medicomp, Inc. — Product Code DRG

K091696 is an FDA 510(k) premarket notification submitted by Medicomp, Inc. for the device "SAVI WIRELESS, MODEL PM500". The FDA issued a decision of Substantially Equivalent on October 26, 2009. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Medicomp, Inc. has at least 10 other 510(k) clearances on record.