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

    TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM

    K Number: K093641 · Decision Dec 8, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    379

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    Basic Information

    Device Name
    TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM
    K Number
    K093641
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tango3, LLC
    Date Received
    November 24, 2009
    Decision Date
    December 8, 2010
    Product Code
    FIN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FIN Tank, Holding, Dialysis

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    Other Clearances by Tango3, LLC

    K Number Device Name
    K140984 TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM