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510(k) Data Aggregation

    K Number
    K250002
    Device Name
    Smart Check O2 (MA0236)
    Manufacturer
    Life Spark Medical, LLC
    Date Cleared
    2025-04-24

    (112 days)

    Product Code
    CCL
    Regulation Number
    868.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Life Spark Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smart Check O2 is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The Smart Check is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes hospitals, nursing homes, extended care facilities, patient homes, and respiratory device service and repair centers.
    Device Description
    The Smart Check O2 is an ultrasonic oxygen analyzer, used to verify the performance of oxygen concentrators. The device is typically used by durable medical equipment technicians while servicing concentrators in their workshops or while visiting patient homes, but it is not left with the patient and is not patient contacting. The device measures the performance of the oxygen concentrator by making ultrasonic time-of-flight measurements, both upstream and downstream. Gas flow rate and oxygen concentration are determined using the resulting data. Temperature and pressure sensors inside the sample cell allow for accurate flow and oxygen readings over the range of specified operating environment conditions. Oxygen and flow readings are shown to the user on the display. The Smart Check O2 can be toggled into a mode for testing pulsing (conserving) oxygen concentrators wherein it displays oxygen concentration and pulse volume instead of flow rate. The user may initiate a pressure check mode by stopping the sample exhaust port with their finger during which the Smart Check O2 measures and displays the maximum pressure generated by the concentrator. The user may also enter a calibration check mode and deliver pure oxygen to the Smart Check O2 to verify its performance. However, it does not require regular calibration after manufacturing. The Smart Check O2 is for prescription use only. Key Components: - Handheld analyzer unit - Removable battery door - Replaceable sample tube - Two Alkaline AA cells
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