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

    BCI WW1020 PULSE OXIMETER, MODEL WW1020

    K Number: K083705 · Decision Apr 9, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    403
    Registration Numbers
    403
    Same Product Code
    711
    Applicant Total
    5
    Review Days
    115

    Basic Information

    Device Name
    BCI WW1020 PULSE OXIMETER, MODEL WW1020
    K Number
    K083705
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SMITHS MEDICAL PM, INC.
    Date Received
    December 15, 2008
    Decision Date
    April 9, 2009
    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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