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

    EKOS ULTRASOUND INFUSION SYSTEM

    K Number: K041826 · Decision Apr 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    23
    Review Days
    294

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    Basic Information

    Device Name
    EKOS ULTRASOUND INFUSION SYSTEM
    K Number
    K041826
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Ekos Corp.
    Date Received
    July 7, 2004
    Decision Date
    April 27, 2005
    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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    Other Clearances by Ekos Corp.

    K Number Device Name
    K081467 EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
    K080392 EndoWave Infusion System
    K073166 ENDOWAVE INFUSION SYSTEM
    K072507 ENDOWAVE INFUSION SYSTEM
    K071933 ENDOWAVE INFUSION SYSTEM
    K063620 EKOS MICRO-INFUSION SYSTEM
    K062508 NEUROWAVE MICRO-INFUSION SYSTEM
    K062507 MICRO-INFUSION SYSTEM
    K060422 LYSUS INFUSION SYSTEM
    K060084 LYSUS INFUSION SYSTEM
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