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

    TSO3 OZONE STERILIZER, MODEL 125L

    K Number: K090636 · Decision Dec 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    25
    Applicant Total
    10
    Review Days
    267

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    Basic Information

    Device Name
    TSO3 OZONE STERILIZER, MODEL 125L
    K Number
    K090636
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tso3, Inc.
    Date Received
    March 10, 2009
    Decision Date
    December 2, 2009
    Product Code
    FLF
    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
    FLF Sterilizer, Ethylene-Oxide Gas

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