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

    VERSARATE FLOW RATE CONTROLER

    K Number: K123729 · Decision Dec 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    437
    Registration Numbers
    437
    Same Product Code
    1167
    Applicant Total
    5
    Review Days
    16

    Basic Information

    Device Name
    VERSARATE FLOW RATE CONTROLER
    K Number
    K123729
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    EMED TECHNOLOGIES CORPORATION
    Date Received
    December 5, 2012
    Decision Date
    December 21, 2012
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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