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

    NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN

    K Number: K123581 · Decision May 9, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    400
    Registration Numbers
    400
    Same Product Code
    725
    Applicant Total
    5
    Review Days
    170

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    Basic Information

    Device Name
    NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN
    K Number
    K123581
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Covidien, Formerly Nellcor Puritan Bennett, Inc.
    Date Received
    November 20, 2012
    Decision Date
    May 9, 2013
    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 Covidien, Formerly Nellcor Puritan Bennett, Inc.

    K Number Device Name
    K123002 VITAL SYNC SYSTEM
    K092847 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION
    K083693 PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
    K082966 PB 540 VENTILATOR