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

    CT3000Pro

    K Number: K212830 · Decision Dec 21, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    105

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    Basic Information

    Device Name
    CT3000Pro
    K Number
    K212830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Srs Medical
    Date Received
    September 7, 2021
    Decision Date
    December 21, 2021
    Product Code
    FEN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FEN Device, Cystometric, Hydraulic

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