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

    STERI-VAC(TM) AERATOR MODEL XL

    K Number: K904921 · Decision Dec 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    7
    Applicant Total
    49
    Review Days
    35

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    Basic Information

    Device Name
    STERI-VAC(TM) AERATOR MODEL XL
    K Number
    K904921
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6100
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    3M Health Care, Ltd.
    Date Received
    October 31, 1990
    Decision Date
    December 5, 1990
    Product Code
    FLI
    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
    FLI Cabinet, Ethylene-Oxide Gas Aerator

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