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    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720

    K Number: K013943 · Decision Dec 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    76
    Applicant Total
    24
    Review Days
    19

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    Basic Information

    Device Name
    RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
    K Number
    K013943
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1110
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radi Medical Systems AB
    Date Received
    November 29, 2001
    Decision Date
    December 18, 2001
    Product Code
    DSK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DSK Computer, Blood-Pressure

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    Other Clearances by Radi Medical Systems AB

    K Number Device Name
    K123984 QUANTIEN MEASUREMENT SYSTEM
    K092105 RADIANALYZER XPRESS
    K080813 PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER
    K080206 MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
    K062769 PRESSUREWIRE CERTUS, MODELS 12006 AND 12306
    K042628 MODIFICATION TO: RADIANALYZER, MODEL 12711
    K033291 TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
    K031662 PRESSURE WIRE SENSOR, MODELS 12004/12304
    K024107 FEMOSTOP FEMORAL COMPRESSION SYSTEM
    K022188 RADIANALYZER, MODEL 12710
    Search all 24 clearances from Radi Medical Systems AB →