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

    Flush Syringe (Prefilled 0.9% normal saline solution)

    K Number: K231724 · Decision Nov 9, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    149

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    Basic Information

    Device Name
    Flush Syringe (Prefilled 0.9% normal saline solution)
    K Number
    K231724
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spm Medicare Pvt. , Ltd.
    Date Received
    June 13, 2023
    Decision Date
    November 9, 2023
    Product Code
    NGT
    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
    NGT Saline, Vascular Access Flush

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    Other Clearances by Spm Medicare Pvt. , Ltd.

    K Number Device Name
    K233794 Insulin Syringe