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

    Automatic Upper Arm Blood Pressure Monitor

    K Number: K193627 · Decision Jul 12, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    428
    Registration Numbers
    428
    Same Product Code
    1216
    Applicant Total
    5
    Review Days
    199

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    Basic Information

    Device Name
    Automatic Upper Arm Blood Pressure Monitor
    K Number
    K193627
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1130
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dongguan E-Test Technology Co., Ltd.
    Date Received
    December 26, 2019
    Decision Date
    July 12, 2020
    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 Dongguan E-Test Technology Co., Ltd.

    K Number Device Name
    K250231 Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)
    K193621 Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)
    K193628 AGE Automatic Wrist Blood Pressure Monitor
    K193624 Automatic Upper Arm Blood Pressure Monitor