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

    Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector

    K Number: K183444 · Decision Sep 9, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    271

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    Basic Information

    Device Name
    Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector
    K Number
    K183444
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6991
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cenorin, LLC
    Date Received
    December 12, 2018
    Decision Date
    September 9, 2019
    Product Code
    LDS
    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
    LDS Device, Pasteurization, Hot Water

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