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

    System 83 Plus Washer/Disinfector

    K Number: K173590 · Decision Mar 30, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    860

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    Basic Information

    Device Name
    System 83 Plus Washer/Disinfector
    K Number
    K173590
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Custom Ultrasonics, Inc.
    Date Received
    November 21, 2017
    Decision Date
    March 30, 2020
    Product Code
    FEB
    Advisory Committee
    Gastroenterology, Urology
    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
    FEB Accessories, Cleaning, For Endoscope

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