BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Insulin Syringe

    K Number: K233794 · Decision Mar 6, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    2
    Review Days
    99

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    Basic Information

    Device Name
    Insulin Syringe
    K Number
    K233794
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spm Medicare Pvt. , Ltd.
    Date Received
    November 28, 2023
    Decision Date
    March 6, 2024
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    FMF Syringe, Piston

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    Other Clearances by Spm Medicare Pvt. , Ltd.

    K Number Device Name
    K231724 Flush Syringe (Prefilled 0.9% normal saline solution)