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

    FIDELITY 200 CARDIAC EVENT RECORDER

    K Number: K071228 · Decision Nov 21, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    1
    Review Days
    202

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    Basic Information

    Device Name
    FIDELITY 200 CARDIAC EVENT RECORDER
    K Number
    K071228
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Signalife, Inc.
    Date Received
    May 3, 2007
    Decision Date
    November 21, 2007
    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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