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

    AIRPURGE

    K Number: DEN080009 · Decision Mar 4, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    1952

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    Basic Information

    Device Name
    AIRPURGE
    K Number
    DEN080009
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    880.5445
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Applicant
    Anesthesia Safety Products, LLC
    Date Received
    October 29, 2008
    Decision Date
    March 4, 2014
    Product Code
    OKL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OKL Intravascular Administration Set, Automated Air Removal System

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