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    K Number
    K974697
    Device Name
    REUSABLE FINGER SENSOR 3444
    Manufacturer
    BCI INTL., INC.
    Date Cleared
    1998-03-11

    (85 days)

    Product Code
    DQH
    Regulation Number
    870.2310
    Why did this record match?
    Product Code :

    DQH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3444 Reusable Finger Sensor is used with BCI oximetry to noninvasively measure oxygen saturation (SpOz), pulse rate and plethysmographic pulse waves. The 3444 sensor is recommended for patients weighing more than 15 kg and patients with limited activity. The 3444 Reusable Finger Sensor is not recommended for prolonged use unless skin integrity is checked frequently and the measurement site is changed accordingly. The Reusable Finger Sensor is for use with BCI International monitors and with monitors that contain BCI International oximelry or are licensed to use BCI International sensors.
    Device Description
    The BCI 3444 Reusable Oximetry Finger Sensor is an updated version of an existing finger sensor, the 3044, legally marketed by BCI International. This updated finger sensor is designed to work with all BCI oximeters. The sensor is made up of three major parts, the cable with the molded connector, the top part of the shell containing the LEDs and the bottom part of the shell containing the photo detector.
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