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)

510(k) number: K252250
Device name: 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)
Applicant: Shanghai Draeger Medical Instrument Co., Ltd. CN
Product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
Decision date: 2026-04-10
Date received: 2025-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Cardiovascular

PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain

Also available from FDA: K252250.pdf

Official FDA record: K252250

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.