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510(k) Data Aggregation

    K Number
    K122927

    Validate with FDA (Live)

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

    (87 days)

    Product Code
    DQA,DOA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter for the Oxicare Fingertip Pulse Oximeter, Model DB11. It does not contain the detailed acceptance criteria for performance, nor does it describe specific studies that prove the device meets such criteria. This letter primarily confirms the FDA's determination of substantial equivalence to a predicate device.

    Therefore, I cannot extract the requested information from this document. The document confirms market clearance but does not elaborate on the technical performance data that led to this clearance.

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