BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DIRECT WRITING VECTORCARDIOGRAPH

    K Number: K810529 · Decision Apr 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    26
    Review Days
    56

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    Basic Information

    Device Name
    DIRECT WRITING VECTORCARDIOGRAPH
    K Number
    K810529
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2400
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Elmed, Inc.
    Date Received
    February 26, 1981
    Decision Date
    April 23, 1981
    Product Code
    DYC
    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
    DYC Vectorcardiograph

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