510(k) K252769
Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) by
Shenzhen Finicare Co., Ltd.
— Product Code DXN
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 2025
- Date Received
- September 2, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type