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

    OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR

    K Number: K051271 · Decision Jan 10, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    42
    Review Days
    238

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    Basic Information

    Device Name
    OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR
    K Number
    K051271
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nellcor Puritan Bennett, Inc.
    Date Received
    May 17, 2005
    Decision Date
    January 10, 2006
    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 Nellcor Puritan Bennett, Inc.

    K Number Device Name
    K070408 DURAMAX REUSABLE OXIMETRY SENSOR
    K060576 NELLCOR OXIMAX N-600X PULSE OXIMETER
    K052186 NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P
    K051352 OXIMAX NPB-40 HANDHELD PULSE OXIMETER
    K050072 GOODKNIGHT 425ST
    K033973 OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR
    K030787 SHILEY FLEXTRA TRACHEOSTOMY TUBE
    K030930 OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-N
    K023494 NELLCOR INDGO MANUAL RESUSCITATOR
    K022819 NELLCOR N-200 PULSE OXIMETER, MODEL N-200
    Search all 42 clearances from Nellcor Puritan Bennett, Inc. →