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

    GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX

    K Number: K014114 · Decision Jun 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    553
    Registration Numbers
    553
    Same Product Code
    738
    Applicant Total
    5
    Review Days
    194

    Basic Information

    Device Name
    GLUCOPRO SYRINGE, MODEL GPSY-XXXXXXXX
    K Number
    K014114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    NIPRO DIABETES SYSTEMS, INC.
    Date Received
    December 14, 2001
    Decision Date
    June 26, 2002
    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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