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

    TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE

    K Number: K965154 · Decision Sep 19, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    19
    Review Days
    270

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    Basic Information

    Device Name
    TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE
    K Number
    K965154
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Albert Browne , Ltd.
    Date Received
    December 23, 1996
    Decision Date
    September 19, 1997
    Product Code
    LRT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Expedited Review
    Y
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRT Indicator, Sterilization

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    TST CONTROL INTEGRATOR FOR STEAM STERILIZERS

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