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

    HEALTHPHONE(TM)

    K Number: K862668 · Decision Dec 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    2
    Review Days
    161

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    Basic Information

    Device Name
    HEALTHPHONE(TM)
    K Number
    K862668
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Carelink
    Date Received
    July 14, 1986
    Decision Date
    December 22, 1986
    Product Code
    DXH
    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
    DXH Transmitters And Receivers, Electrocardiograph, Telephone

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    Other Clearances by Carelink

    K Number Device Name
    K874631 HEALTHPHONE TOCO MODEL