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510(k) Data Aggregation

    K Number
    K201699
    Device Name
    Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor
    Manufacturer
    Surgical Instrument and Savings Inc (dba Medline ReNewal)
    Date Cleared
    2020-07-22

    (30 days)

    Product Code
    NLF
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Surgical Instrument and Savings Inc (dba Medline ReNewal)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor Model MAXNAR is indicated for single patient use when continuous non-invasive arterial oxygen saturation and pulse rate monitoring is required for adult patients as indicated in the sensor directions for use. This device is for prescription use only.
    Device Description
    The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR is designed for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in conjunction with a Nellcor Pulse Oximeter. The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor, model MAXNAR, is intended for prescription use with adult patients in hospitals, hospital-type facilities, and intra-hospital transport. The proposed device is not provided sterile
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