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

    BCI WW1021 PC APPLICATION

    K Number: K090205 · Decision Apr 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    BCI WW1021 PC APPLICATION
    K Number
    K090205
    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
    January 28, 2009
    Decision Date
    April 28, 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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    Other Clearances by Smiths Medical Pm, Inc.

    K Number Device Name
    K083557 BCI WW1030 PULSE OXIMETER
    K083787 BCI WW1000 PULSE OXIMETER, MODEL WW1000
    K083705 BCI WW1020 PULSE OXIMETER, MODEL WW1020
    K070732 BCI AUTOCON 3304 DIGITAL PULSE OXIMETER