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

    Remunity System

    K Number: K243354 · Decision Nov 27, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    3
    Applicant Total
    10
    Review Days
    29

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    Basic Information

    Device Name
    Remunity System
    K Number
    K243354
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5725
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Deka Research & Development Corp.
    Date Received
    October 29, 2024
    Decision Date
    November 27, 2024
    Product Code
    QJY
    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
    QJY Infusion Pump, Drug Specific, Pharmacy-Filled

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