BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000

    K Number: K072185 · Decision Mar 27, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    52
    Applicant Total
    1
    Review Days
    234

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    Basic Information

    Device Name
    AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000
    K Number
    K072185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5045
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Airistar Technologies, LLC
    Date Received
    August 6, 2007
    Decision Date
    March 27, 2008
    Product Code
    FRF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRF Cleaner, Air, Medical Recirculating

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