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

    PRIMUS Healthcare Sterilizer (Model PSS11-HC)

    K Number: K221474 · Decision Feb 10, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    4
    Review Days
    266

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    Basic Information

    Device Name
    PRIMUS Healthcare Sterilizer (Model PSS11-HC)
    K Number
    K221474
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Primus Sterilizer Company, LLC
    Date Received
    May 20, 2022
    Decision Date
    February 10, 2023
    Product Code
    FLE
    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
    FLE Sterilizer, Steam

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    Other Clearances by Primus Sterilizer Company, LLC

    K Number Device Name
    K233132 PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)
    K093333 PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8
    K082817 PRIMUS STEAM STERILIZER, MODELS PSS5-G-1 AND PSS5-M