510(k) K092947

TELESENTRY, MODEL TS01 by Scottcare Corporation — Product Code DSI

K092947 is an FDA 510(k) premarket notification submitted by Scottcare Corporation for the device "TELESENTRY, MODEL TS01". The FDA issued a decision of Substantially Equivalent on February 26, 2010. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Scottcare Corporation has at least 4 other 510(k) clearances on record.