K253170
- 510(k) number
- K253170
- Device name
- uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. CN
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2026-04-16
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K253170.pdf
Official FDA record: K253170
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.