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510(k) Data Aggregation

    K Number
    K023733
    Device Name
    COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR
    Manufacturer
    INGENJORSFIRMAN BJORN BERGDAHL AB
    Date Cleared
    2003-05-14

    (189 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Abbreviated
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K870149,K870177
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Coagulation of soft tissue during surgery.

    Device Description

    Coa-Comp/M Automatic Bipolar Coagulator. Class II device. For coagulation of soft tissue during surgery using Radio Frequency, a pure sine-wave with frequency 512 kHz. Maximum power output 40W into 100 Ohms.

    AI/ML Overview

    The provided text is a 510(k) summary for the Coa-Comp/M Automatic Bipolar Coagulator. It focuses on establishing substantial equivalence to predicate devices and does NOT contain information regarding acceptance criteria, device performance studies, or details about training/test sets as would be required for an AI/ML device.

    Therefore, I cannot provide the requested information. The document is primarily an administrative declaration of substantial equivalence for a non-AI medical device.

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