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

    Accutension Smartphone Auscultatory Blood

    K Number: K180335 · Decision Mar 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    Accutension Smartphone Auscultatory Blood
    K Number
    K180335
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai Hulu Devices Co., Ltd.
    Date Received
    February 6, 2018
    Decision Date
    March 8, 2018
    Product Code
    DXQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    DXQ Blood Pressure Cuff

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    Other Clearances by Shanghai Hulu Devices Co., Ltd.

    K Number Device Name
    K220470 Smart Wireless Stethoscope