BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    MOORLDLS LASER DOPPLER LINE SCANNER

    K Number: K063561 · Decision Jan 19, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    47
    Applicant Total
    13
    Review Days
    53

    Basic Information

    Device Name
    MOORLDLS LASER DOPPLER LINE SCANNER
    K Number
    K063561
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MOOR INSTRUMENTS LTD.
    Date Received
    November 27, 2006
    Decision Date
    January 19, 2007
    Product Code
    DPT
    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
    DPT Probe, Blood-Flow, Extravascular

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    Other Clearances by MOOR INSTRUMENTS LTD.

    K Number Device Name
    K132163 MOORLDLS-BI LASER DOPPLER BURNS IMAGER
    K122943 MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
    K112826 NOORVMS-OXY TISSUE OXYGEN AND TEMPERTURE MONITOR
    K102433 MOORVMS-PRES PRESSURE CUFF CONTROLLER
    K083082 MOORVMS-LDF1 AND MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS
    K060976 MOORLD12-B1 LASER DOPPLER BURNS IMAGER
    K063586 MOORFLPI FULL-FIELD LASER PERFUSION IMAGER
    K032841 MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR
    K011070 DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR
    K980383 MOOORLDI LASER DOPPLER IMAGER
    Search all 13 clearances from MOOR INSTRUMENTS LTD. →