510(k) K905506

ACCUCORE TELEMETRY, MODIFICATION by S & W Medico Teknik — Product Code DSI

K905506 is an FDA 510(k) premarket notification submitted by S & W Medico Teknik for the device "ACCUCORE TELEMETRY, MODIFICATION". The FDA issued a decision of Substantially Equivalent on September 6, 1991. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. S & W Medico Teknik has at least 10 other 510(k) clearances on record.