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510(k) Data Aggregation

    K Number
    K251693
    Device Name
    Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)
    Manufacturer
    Unimed Medical Supplies, Inc.
    Date Cleared
    2025-11-18

    (169 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K142832
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Unimed Reusable SpO2 Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.

    Device Description

    The subject device is Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensor is designed for compatibility with CSI 8100EP1, and is supplied non-sterile.
    The sensor consists of a connector, a cable, and a finger clip housing incorporating a light-emitting diode (LED) and photodetector (PD). The subject device operates on the same principle and share similar design features, materials, and performance characteristics as the predicate device.

    AI/ML Overview

    N/A

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