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

    QUANTIEN MEASUREMENT SYSTEM

    K Number: K123984 · Decision Mar 28, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    178
    Registration Numbers
    178
    Same Product Code
    429
    Applicant Total
    24
    Review Days
    92

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    Basic Information

    Device Name
    QUANTIEN MEASUREMENT SYSTEM
    K Number
    K123984
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1425
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radi Medical Systems AB
    Date Received
    December 26, 2012
    Decision Date
    March 28, 2013
    Product Code
    DQK
    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
    DQK Computer, Diagnostic, Programmable

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    Other Clearances by Radi Medical Systems AB

    K Number Device Name
    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
    K022187 PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
    Search all 24 clearances from Radi Medical Systems AB →