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510(k) Data Aggregation

    K Number
    K142209
    Device Name
    Pulse oximeter NBM-200
    Manufacturer
    ORSENSE LTD
    Date Cleared
    2015-01-16

    (158 days)

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

    ORSENSE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NBM-200 is a portable Hemoglobin and oximetry monitor. It non-invasively spot checks and displays Hemoglobin (Hb), estimated Hematocrit (Hct) values, functional saturation of arterial oxygen hemoglobin (SpO2), and pulse rate (PR). These parameters can be displayed periodically for patient monitoring. The monitor estimates Hct via a calculation based on the Hb measurement for normal hemoglobin values (11 to 17 g/dl) only and abnormal values will not be displayed. It is intended for use by trained medical personnel, with adult individuals, in non-critical clinical and non-clinical settings (e.g. non-critical settings in hospitals, hospital-type facilities, mobile environments, clinics, physician offices and ambulatory surgery centers). In this context, non-critical means patient examination settings where continuous monitoring is unnecessary. Non-critical environments exclude, for example, intensive care units.
    Device Description
    The NBM-200 is a portable Hemoglobin and oximetry monitor, based on occlusion spectroscopy technology, for non-invasive spot checking of hemoglobin (Hb), estimated Hematocrit (Hct), SpO2 and pulse rate. The NBM-200 includes a reusable ring-shaped sensor probe that fits on the patient's finger, and a portable desktop monitor that calculates and displays the measurement result. The sensor probe consists of a multi-wavelength optical measuring system and inflatable cuff employing pneumatic tissue manipulation. Blood flow in the finger can be briefly occluded and the resulting changes in its optical behavior are analyzed to provide accurate measurements of Hb.
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    K Number
    K124041
    Device Name
    NBM-200MP
    Manufacturer
    ORSENSE LTD
    Date Cleared
    2013-10-17

    (293 days)

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

    ORSENSE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NBM-200MP is a portable Hemoglobin and oximetry monitor. It non-invasively monitors and displays Hemoglobin (Hb), estimated Hematocrit (Hct), functional saturation of arterial oxygen hemoglobin (SpO2), temporary occluded blood oxygen saturation (SoO2), pulse rate (PR) and plethysmogram waveform. For oximetry (SpO2/SoO2), the NBM-200MP permits continuous patient monitoring with adjustable alarm limits, as well as visible and audible alarm signals. SoO2 is intended for use in low perfusion conditions and under any conditions that will cause poor signal quality. The NBM-200MP periodically displays Hemoglobin (Hb) and estimated Hematocrit (Hct) values and it can also be used for spot measurements. The monitor estimates Hct via a calculation based on the Hb measurement for normal hemoglobin values (i.e. 11 to 17 g/dl) only and abnormal values will not be displayed. It is intended for use by trained medical personnel, with adult individuals, in clinical and non-clinical settings (e.g. hospitals, hospital-type facilities, mobile environments, clinics, physician offices and ambulatory surgery centers).
    Device Description
    OrSense NBM-200MP device is a pulse oximetry and hemoglobin monitoring device, measuring SpO2, pulse rate, hemoglobin and estimated Hematocrit. In addition to a regular operating mode, it also includes an "occlusion spectroscopy" mode, which is activated during low-perfusion conditions for oximetry (SoO2) and for Hb measurements. The sensor probe pneumatic cuff is placed around a finger and briefly inflates and deflates; the resulting changes in blood optical behavior within the finger are measured and analyzed to provide accurate measurements of SoO2 during low-perfusion conditions and Hemoglobin values at predetermined time intervals. The monitor should not be used under any circumstances as a substitute for an approved lab blood analyzer.
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    K Number
    K091564
    Device Name
    NBM-200MP PULSE OXIMETRY DEVICE
    Manufacturer
    ORSENSE LTD
    Date Cleared
    2010-03-19

    (295 days)

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

    ORSENSE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NMB-200MP is a portable Oximetry monitor which may be used in low perfusion conditions. It non-invasively and continuously monitors and displays arterial blood oxygen saturation (SpO2), temporary occluded arterial blood oxygen saturation (SoO2), pulse rate (P.R.) and plethysmogram waveform. Temporary occluded arterial blood oxygen saturation (SoO2) is intended for use under any conditions that will cause poor signal quality. It is not intended for use under motion conditions. It may be used on adult patients in the hospital or clinical environments. The NBM-200MP permits continuous patient monitoring with adjustable alarm limits for oximetry, as well as visible and audible alarm signals. The NBM-200MP is NOT intended for home use.
    Device Description
    OrSense NBM-200MP device is a pulse oximetry device, measuring SpO2 and Pulse Rate. In addition to a regular operating mode, it also includes an "occlusion spectroscopy" mode, which is activated during low-perfusion conditions. A pneumatic cuff placed around a finger temporarily inflates and deflates; the resulting changes in blood behavior within the occluded finger are measured and analyzed to provide accurate measurements of blood oxygen saturation during low-perfusion conditions.
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