BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)

    K Number: K241578 · Decision Feb 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    420
    Registration Numbers
    420
    Same Product Code
    1186
    Applicant Total
    5
    Review Days
    261

    Basic Information

    Device Name
    Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)
    K Number
    K241578
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen BSX Technology Electronics Co., Ltd.
    Date Received
    June 3, 2024
    Decision Date
    February 19, 2025
    Product Code
    DXN
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.

    G0 Blood Pressure Monitoring System (G0)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Globalcare Blood Pressure Monitor (GUS610)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Shenzhen BSX Technology Electronics Co., Ltd.

    K Number Device Name
    K230097 IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
    K202296 Infrared Forehead Thermometer, Model BSX976
    K202324 Fingertip Pulse Oximeter
    K183058 Arm-type Electronic Blood Pressure Monitor