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

    DAXOR MAX100 SYRINGE (MAX100)

    K Number: K970419 · Decision Dec 22, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    553
    Registration Numbers
    553
    Same Product Code
    738
    Applicant Total
    2
    Review Days
    321

    Basic Information

    Device Name
    DAXOR MAX100 SYRINGE (MAX100)
    K Number
    K970419
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    DAXOR CORPORATION
    Date Received
    February 4, 1997
    Decision Date
    December 22, 1997
    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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