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510(k) Data Aggregation

    K Number
    K023693
    Device Name
    MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
    Manufacturer
    AIREX INC.
    Date Cleared
    2003-03-12

    (131 days)

    Product Code
    FRF
    Regulation Number
    880.5045
    Why did this record match?
    Applicant Name (Manufacturer) :

    AIREX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The M-100 system is intended for use in filtering airborne particles from air for medical purposes.
    Device Description
    The M-100 is a portable HEPA-Filtered clean hood for use in providing a controlled environment to class 100 (ISO class 3,5) for medical applications that require a high degree of airborne particulate control. The system is controlled by embedded firmware and runs on standard 120volt, 5 amp power. Pushbutton Controls include airflow, light intensity, lift/lower. Manual controls include Filter tilt/angle, brakes.
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