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

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

    K Number: K250548 · Decision Jun 26, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    420
    Registration Numbers
    420
    Same Product Code
    1186
    Applicant Total
    3
    Review Days
    121

    Basic Information

    Device Name
    Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
    K Number
    K250548
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    JOYTECH Healthcare Co., Ltd.
    Date Received
    February 25, 2025
    Decision Date
    June 26, 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

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    Other Clearances by JOYTECH Healthcare Co., Ltd.

    K Number Device Name
    K243468 Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
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