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510(k) Data Aggregation

    K Number
    K122927
    Device Name
    OXICARE FINGERTIP PULSE OXIMETER
    Manufacturer
    DELBIO INCORPORATED
    Date Cleared
    2012-12-20

    (87 days)

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

    DELBIO INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OxiCare Fingertip Pulse Oximeter, model DB11 is indicated for spot-checking of functional arterial oxygen saturation (SpO2) and pulse rate (PR) of adult and pediatric patients in hospitals, physician's office, clinical settings and home care environment. The OxiCare Fingertip Pulse Oximeter, model DB11 is not intended for continuous monitoring.
    Device Description
    Not Found
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