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510(k) Data Aggregation

    K Number
    K243926
    Device Name
    Vivatmo pro-S
    Date Cleared
    2025-09-11

    (265 days)

    Product Code
    Regulation Number
    862.3080
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Vivatmo pro-S

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