510(k) K253170
uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors by
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
— Product Code MHX
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2026
- Date Received
- September 26, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type