510(k) K900319

SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM by Siemens Medical Electronics — Product Code DSI

K900319 is an FDA 510(k) premarket notification submitted by Siemens Medical Electronics for the device "SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 28, 1990. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Siemens Medical Electronics has at least 10 other 510(k) clearances on record.