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

    MODIFICATION TO SYSTEM 83 PLUS

    K Number: K983017 · Decision Sep 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    11
    Applicant Total
    4
    Review Days
    25

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    Basic Information

    Device Name
    MODIFICATION TO SYSTEM 83 PLUS
    K Number
    K983017
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Custom Ultrasonics
    Date Received
    August 28, 1998
    Decision Date
    September 22, 1998
    Product Code
    NVE
    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
    NVE Washer, Cleaner, Automated, Endoscope

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    Other Clearances by Custom Ultrasonics

    K Number Device Name
    K122172 SYSTEM 83 PLUS
    K061430 SYSTEM 83 PLUS MINIFLEX WASHER-DISINFECTOR
    K842754 CUSTOM ULTRASONICS-SYS 80, 81-24, 83-2