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510(k) Data Aggregation

    K Number
    K964239
    Device Name
    COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER
    Manufacturer
    SPEGAS INDUSTRIES, LTD.
    Date Cleared
    1997-05-09

    (198 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPEGAS INDUSTRIES, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The Spegas MicroCap/NPB-75 and the comparison device Gemini+ (K950387) are integrated instruments that measure end tidal CO2 (EtCO2) and saturated arterial oxygen (SpO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR) and as a derivative of the saturated arterial oxygen measurement the devices measure and display the pulse rate (PR). The capnograph section of both devices function as a carbon dioxide gas analyzer that measures in mmHg, Vol %, or kPa the concentration of CO2 in a gas mixture to aid in determining the patient's ventilatory status. The pulse oximeter module in both devices measures the oxygenated hemoglobin (HbO2) and displays the results as a percent of oxygen and as a plethysmographic waveform. The Spegas MicroCap/NPB-75 pulse oximeter module is essentially identical to the Spegas Gemini+ (K950387) pulse oximeter module. The Gemini+ uses the Nellcor M-203 Spon module and the MicroCap/NPB-75 utilizes the Nellcor MP-204 module. The MP-204 SpO2 module is very similar, essentially equivalent, to the MP-203 module. Spegas integrates the Nellcor MP-204, without alteration, into the MicroCap/NPB-75 and Gemini (MP203).
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