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

    DRAGON HEART PISTON SYRINGE

    K Number: K042547 · Decision Dec 1, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    2
    Review Days
    72

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    Basic Information

    Device Name
    DRAGON HEART PISTON SYRINGE
    K Number
    K042547
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dragon Heart Medical Devices Co., Ltd.
    Date Received
    September 20, 2004
    Decision Date
    December 1, 2004
    Product Code
    FMF
    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
    FMF Syringe, Piston

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    Other Clearances by Dragon Heart Medical Devices Co., Ltd.

    K Number Device Name
    K043235 DRAGON HEART I.V. SET