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510(k) Data Aggregation

    K Number
    K173807
    Device Name
    Accu O2 Oxygen Analyzer
    Manufacturer
    Precision Medical Inc.
    Date Cleared
    2018-05-02

    (138 days)

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

    Precision Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PM5950 Accu O2 Analyzer is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air/oxygen mixture. The PM5950 Accu O2 Analyzer is not intended for use in continuous monitoring of oxygen delivery to patient.
    Device Description
    The PM5950 Accu O2 Analyzer measures and displays the amount of oxygen present, percent (%), in an air/oxygen breathing circuit. Oxygen measurement is accomplished by placing an oxygen sensor into a breathing circuit. The sensor employs amperometric electrochemical measurement principles (e.g. galvanic fuel cell; lead oxygen battery). The sensor is connected to the analyzer unit via an interface cable. The analyzer unit is battery powered. The analyzer is microprocessor based and interfaces with user push buttons and a LCD display. User push buttons allow the user to turn the unit on/off and to initiate calibration. The LCD provides indication of the per-cent oxygen measured, low battery indication and calibration required. The device consists of four basic elements: Base Device, Extendible Cable, Oxygen Sensor W/ Diverter Fitting, and Tee Adaptor.
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