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

    DIGITAL ELECTROCARDIOGRAPH

    K Number: K133985 · Decision Jan 22, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    5
    Review Days
    392

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    Basic Information

    Device Name
    DIGITAL ELECTROCARDIOGRAPH
    K Number
    K133985
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
    Date Received
    December 26, 2013
    Decision Date
    January 22, 2015
    Product Code
    DPS
    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
    DPS Electrocardiograph

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    Other Clearances by Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

    K Number Device Name
    K160092 Digital Electrocardiograph
    K152384 Digital Electrocardiograph
    K141946 DIGITAL ELECTROCARDIOGRAPH
    K132758 DIGITAL ELECTROCARDIOGRAPH