BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves

    K Number: K181456 · Decision Jul 8, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    4
    Review Days
    399

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    Basic Information

    Device Name
    Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves
    K Number
    K181456
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Tuttnauer , Ltd.
    Date Received
    June 4, 2018
    Decision Date
    July 8, 2019
    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 , Ltd.

    K Number Device Name
    K222608 Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS
    K221227 Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
    K213080 T-Edge 10, T-Edge 11