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510(k) Data Aggregation

    K Number
    K132516
    Device Name
    OXIPROBE E (OXIPROBE)
    Date Cleared
    2014-07-30

    (352 days)

    Product Code
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO MEDICAL TECHNOLOGIES CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OxiprobE is indicated for non-invasive, continuous, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate, and pulse amplitude. Individual models are labeled for the intended use. It is for prescription use only.
    Device Description
    The OxiprobE Pulse Oximetry Sensors are used for non-invasive measurement of blood oxygen saturation and pulse rate measurement. The disposable sensors are designed to enable the sensor's light source and photo detector to be securely and properly positioned on the patient. The adhesive stabilizes these important optical components and provides a comfortable fit. The adhesive sensors are patient-dedicated and can travel with the patients. The single-use, disposable sensors do not present the risk of cross-contamination caused by products that are reused from patient to patient. This 510(k) seeks premarket clearance for a line extension model BM-500, compatible with the BM-2070 extension cable and the Nellcor N-395 Pulse Oximeter (a legacy oximeter.). The BM-2070 extension cable was cleared for use with the predicate BMT sensors under K092549.
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    K Number
    K092549
    Device Name
    OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P
    Date Cleared
    2009-11-16

    (89 days)

    Product Code
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO MEDICAL TECHNOLOGIES CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OxiprobE is indicated for non-invasive, continuus, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate and pulse amplitude. Individual models are labeled specifically for either adult or pediatric use. It is for prescription use only.
    Device Description
    The Oxiproble is Pulse Oximetry sensors and cables used for non-invasive measurement of blood oxygen saturation and pulse rute measurement. It consists of Connector, Cable and sensor. Bio Medical Technologies Co., Ltd. supplies both disposable and reusable sensors. Disposable sensors are designed to enable the sensor's light source and photo detector to be securely and properly positioned on the patient. The adhesive stabilizes these important optical components and provides a comfortable fit. Adhesive sensors are patient-dedicated and can travel with your patients. Single-use sensors do not present the risk of cross-contamination caused by products that are reused from patient up patient. Reusable sensors are designed to monitor various sizes of relatively immobile patients. When short-term or intermittent monitoring is necessary, these reusable, nonsterile sensors are an effective monitoring alternative.
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