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510(k) Data Aggregation

    K Number
    K003876
    Date Cleared
    2001-07-09

    (206 days)

    Product Code
    Regulation Number
    884.2660
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    US SENSOR #CG-930P; TOCO SENSOR CG-940P

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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