510(k) K012336

MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 by Medical Data Electronics — Product Code DSI

K012336 is an FDA 510(k) premarket notification submitted by Medical Data Electronics for the device "MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500". The FDA issued a decision of Substantially Equivalent on October 3, 2001. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Medical Data Electronics has at least 10 other 510(k) clearances on record.