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

    Carnation Ambulatory Monitor

    K Number: K233110 · Decision Nov 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    7
    Review Days
    56

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    Basic Information

    Device Name
    Carnation Ambulatory Monitor
    K Number
    K233110
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bardy Diagnostics, Inc.
    Date Received
    September 27, 2023
    Decision Date
    November 22, 2023
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

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    Other Clearances by Bardy Diagnostics, Inc.

    K Number Device Name
    K210036 Carnation Ambulatory Monitor (CAM)
    K200870 Carnation Ambulatory Monitor
    K192556 Carnation Ambulatory Monitor
    K191471 Carnation Ambulatory Monitor
    K191000 Carnation Ambulatory Monitor
    K143067 Carnation Ambulatory Monitor