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

    Sterilucent HC 80TT Hydrogen Peroxide Sterilizer

    K Number: K190005 · Decision Sep 13, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    46
    Applicant Total
    7
    Review Days
    254

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    Basic Information

    Device Name
    Sterilucent HC 80TT Hydrogen Peroxide Sterilizer
    K Number
    K190005
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sterilucent, Inc.
    Date Received
    January 2, 2019
    Decision Date
    September 13, 2019
    Product Code
    MLR
    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
    MLR Sterilizer, Chemical

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    Other Clearances by Sterilucent, Inc.

    K Number Device Name
    K192001 Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device
    K191999 Sterilucent VH2O2 Chemical Indicators
    K142109 STERILUCENT STERILIZATION CONTAINER SYSTEM
    K141238 STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR
    K140464 STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZER
    K141312 STERILUCENT PROCESS CHALLENGE DEVICE