BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    STERIZONE VP4 Sterilizer

    K Number: K153392 · Decision Mar 24, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    121

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    Basic Information

    Device Name
    STERIZONE VP4 Sterilizer
    K Number
    K153392
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ts03, Inc.
    Date Received
    November 24, 2015
    Decision Date
    March 24, 2016
    Product Code
    PJJ
    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
    PJJ Two Or More Sterilant Sterilizer

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