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510(k) Data Aggregation

    K Number
    K233501
    Date Cleared
    2024-07-26

    (269 days)

    Product Code
    Regulation Number
    868.2375
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)

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