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510(k) Data Aggregation

    K Number
    K970586
    Date Cleared
    1997-05-12

    (87 days)

    Product Code
    Regulation Number
    892.5050
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAINLAB MED. COMPUTERSYSTEME GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K954861
    Date Cleared
    1996-08-05

    (287 days)

    Product Code
    Regulation Number
    892.5050
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAINLAB MED. COMPUTERSYSTEME GMBH

    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
    K952390
    Date Cleared
    1996-02-02

    (256 days)

    Product Code
    Regulation Number
    882.4560
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRAINLAB MED. COMPUTERSYSTEME GMBH

    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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