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

    SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES

    K Number: K062149 · Decision May 31, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    403
    Registration Numbers
    403
    Same Product Code
    711
    Applicant Total
    2
    Review Days
    308

    Basic Information

    Device Name
    SP02 SENSOR FS AND PS 'SILC-TOUCH' SERIES; SP02 SENSOR FC, FP AND Y SERIES
    K Number
    K062149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    INTERNATIONAL BUSINESS STRATEGIES
    Date Received
    July 27, 2006
    Decision Date
    May 31, 2007
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    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
    DQA Oximeter

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