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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.

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.

The provided text is a 510(k) summary for the NBM-200 Pulse Oximeter and Hemoglobin Monitor. It describes the device, its intended use, and its substantial equivalence to a predicate device (NBM 200MP). However, it explicitly states, "Clinical data for the predicate NBM 200-MP were submitted for the K124041 clearance and no clinical data were generated for the modified device."

This means that the document does not contain the acceptance criteria or the study details for the NBM-200 itself. It relies on the clinical data and acceptance criteria established for the predicate device (NBM 200MP) from its K124041 submission.

Therefore, I cannot extract the requested information from the provided text for the NBM-200. The document states that no clinical data was generated specifically for the NBM-200 device.

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