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510(k) Data Aggregation

    K Number
    K011746
    Device Name
    MB 11
    Manufacturer
    MAICO DIAGNOSTIC GMBH
    Date Cleared
    2001-08-24

    (79 days)

    Product Code
    GWJ
    Regulation Number
    882.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAICO DIAGNOSTIC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Maico MB 11 is intended to generate evoked auditory brainstem response (ABR) - based measurements for both child and newborn hearing screening.
    Device Description
    Not Found
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