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

    NEUROWAVE MICRO-INFUSION SYSTEM

    K Number: K062508 · Decision Dec 5, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    23
    Review Days
    99

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    Basic Information

    Device Name
    NEUROWAVE MICRO-INFUSION SYSTEM
    K Number
    K062508
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Ekos Corp.
    Date Received
    August 28, 2006
    Decision Date
    December 5, 2006
    Product Code
    NUI
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NUI Ultrasound, Infusion, System

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