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

    STEAM STERILIZER

    K Number: K831356 · Decision Jul 18, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    4
    Review Days
    449

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    Basic Information

    Device Name
    STEAM STERILIZER
    K Number
    K831356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Ars Enterprises, Inc.
    Date Received
    April 26, 1983
    Decision Date
    July 18, 1984
    Product Code
    FLE
    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
    FLE Sterilizer, Steam

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    Other Clearances by Ars Enterprises, Inc.

    K Number Device Name
    K852115 ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER
    K852114 ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000
    K852113 ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81