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

    AMERICAN GOLD SERIES AUTOCLAVE

    K Number: K833837 · Decision Jan 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    6
    Review Days
    69

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    Basic Information

    Device Name
    AMERICAN GOLD SERIES AUTOCLAVE
    K Number
    K833837
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Tuttnauer Co. , Ltd.
    Date Received
    November 3, 1983
    Decision Date
    January 11, 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 Tuttnauer Co. , Ltd.

    K Number Device Name
    K111736 TUTTNAUER EZ PLUS SERIES ELECTRONIC TABLETOP AUTOCLAVES
    K063711 TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L USA SP-2A, 69180 SP-2HA
    K003470 EHS SERIES TABLE TOP AUTOCLAVE, MODELS 2540 AND 3870
    K920478 TUTTNAUER LSI (AUTOMATIC)
    K850264 TUTTNAUER PRE-VACUUM AUTOCLAVE