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

    HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)

    K Number: K111339 · Decision Jun 8, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    14
    Applicant Total
    209
    Review Days
    27

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    Basic Information

    Device Name
    HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
    K Number
    K111339
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    864.5680
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic, Inc.
    Date Received
    May 12, 2011
    Decision Date
    June 8, 2011
    Product Code
    JOX
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JOX Analyzer, Heparin, Automated

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