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510(k) Data Aggregation

    K Number
    K960861
    Device Name
    OMICRON MONITOR, DELTA MONITOR
    Manufacturer
    CORE-M, INC.
    Date Cleared
    1996-08-19

    (171 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    CORE-M, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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