510(k) K220113
Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) by
Shenzhen Finicare Co., Ltd.
— Product Code DXN
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2022
- Date Received
- January 14, 2022
- Clearance Type
- Traditional
- 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