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

    SONIXGPS

    K Number: K121812 · Decision Dec 2, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    151
    Applicant Total
    11
    Review Days
    530

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    Basic Information

    Device Name
    SONIXGPS
    K Number
    K121812
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ultrasonix Medical Corporation
    Date Received
    June 20, 2012
    Decision Date
    December 2, 2013
    Product Code
    BSP
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

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    Other Clearances by Ultrasonix Medical Corporation

    K Number Device Name
    K111818 SONIXGPS NEEDLE SENSOR
    K113663 SONIXTABLET ULTRASOUND SCANNER
    K112726 SONIX ULTRASOUND SCANNER
    K102997 SONIXTABLET ULTRASOUND SCANNER
    K093462 SONIX ULTRASOUND SCANNER
    K083095 SONIXTOUCH ULTRASOUND SYSTEM
    K080935 SONIX MDP ULTRASOUND SCANNER
    K061827 SONIX ULTRASOUND SCANNER
    K042326 ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER
    K020630 ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER
    Search all 11 clearances from Ultrasonix Medical Corporation →