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510(k) Data Aggregation

    K Number
    K233110
    Device Name
    Carnation Ambulatory Monitor
    Manufacturer
    Bardy Diagnostics, Inc.
    Date Cleared
    2023-11-22

    (56 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bardy Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.
    Device Description
    Not Found
    Ask a Question
    K Number
    K210036
    Device Name
    Carnation Ambulatory Monitor (CAM)
    Manufacturer
    Bardy Diagnostics, Inc.
    Date Cleared
    2021-02-05

    (30 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bardy Diagnostics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.
    Device Description
    Not Found
    Ask a Question
    K Number
    K143067
    Device Name
    Carnation Ambulatory Monitor
    Manufacturer
    BARDY DIAGNOSTICS, INC.
    Date Cleared
    2014-12-22

    (59 days)

    Product Code
    DSH, MWJ
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    BARDY DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carnation Ambulatory Monitor is designed to provide extended duration cardiac monitoring for people who are suspected of having cardiac arrhythmias.
    Device Description
    Not Found
    Ask a Question

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