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510(k) Data Aggregation

    K Number
    K251695
    Device Name
    Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)
    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 (U403S-06) is Unimed Reusable SpO2 Sensor and are fully compatible for use with BCI SPECTRO2 10. The sensor is supplied non-sterile.

    The subject sensor consists of a plug/connector (BCI DB9 sensor connector), a cable (1.1 m), and a patient-contacting sensor (soft tip: U403S-06) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensor shares the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Also, the subject sensor has identical material composition and performance characteristics to the predicate device.

    The purpose of the submission is to receive clearance to market U403S-06 under their own 510k.

    AI/ML Overview

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