K250349
- 510(k) number
- K250349
- Device name
- Vista CMS
- Applicant
- Shanghai Draeger Medical Instrument Co., Ltd. CN
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2026-04-24
- Date received
- 2025-02-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K250349.pdf
Official FDA record: K250349
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.