510(k) K252250

Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) by Shanghai Draeger Medical Instrument Co., Ltd. — Product Code MHX

K252250 is an FDA 510(k) premarket notification submitted by Shanghai Draeger Medical Instrument Co., Ltd. for the device "Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)". The FDA issued a decision of Substantially Equivalent on April 10, 2026. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Shanghai Draeger Medical Instrument Co., Ltd. has at least 2 other 510(k) clearances on record.