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510(k) Data Aggregation

    K Number
    K964204
    Device Name
    ENGSTROM HMEF 1000
    Manufacturer
    DATEX ENGSTROM AB
    Date Cleared
    1996-11-13

    (76 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATEX ENGSTROM AB

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