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

    ReddyPort Elbow

    K Number: K231064 · Decision Jul 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    46
    Applicant Total
    2
    Review Days
    90

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    Basic Information

    Device Name
    ReddyPort Elbow
    K Number
    K231064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smd Manufacturing, LLC
    Date Received
    April 14, 2023
    Decision Date
    July 13, 2023
    Product Code
    MNS
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MNS Ventilator, Continuous, Non-Life-Supporting

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    Other Clearances by Smd Manufacturing, LLC

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