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

    P.H.D. - PERSONAL HEART DEVICE MODEL 5258

    K Number: K963904 · Decision May 15, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    1
    Review Days
    227

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    Basic Information

    Device Name
    P.H.D. - PERSONAL HEART DEVICE MODEL 5258
    K Number
    K963904
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Heart Alert, Inc.
    Date Received
    September 30, 1996
    Decision Date
    May 15, 1997
    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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