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510(k) Data Aggregation

    K Number
    K001564
    Manufacturer
    Date Cleared
    2000-11-24

    (189 days)

    Product Code
    Regulation Number
    882.1400
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEURO SCAN LABS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K001562
    Manufacturer
    Date Cleared
    2000-08-16

    (89 days)

    Product Code
    Regulation Number
    890.1375
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEURO SCAN LABS

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

    Ask a specific question about this device

    K Number
    K001324
    Manufacturer
    Date Cleared
    2000-07-11

    (76 days)

    Product Code
    Regulation Number
    882.1400
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEURO SCAN LABS

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

    Ask a specific question about this device

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