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

    CARDIOSENTRY EVENT MONITOR, MODEL 8470-01

    K Number: K001634 · Decision Dec 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    15
    Review Days
    209

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    Basic Information

    Device Name
    CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
    K Number
    K001634
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tz Medical, Inc.
    Date Received
    May 26, 2000
    Decision Date
    December 21, 2000
    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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