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The MTEK-40 hand held pulse oximeter is used to measure the percent arterial oxygen saturation by using a completely non-invasive finger sensor. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed. The MTEK-40 can also measure pulse rate and pulse strength. Continuous arterial oxygen saturation monitoring is valuable in any situation where oxygen administration is indicated. Real time information allows for earlier detection of hypoxia or hyperoxia tan arterial sampling. Federal Law restricts the use of this device by or on the order of a qualified physician only.

Hand Held Pulse Oximeter, Device Model: MTEK-40. The oxygen saturation sensor contains LEDs which emit two specific wavelengths of light through a pulsating vascular bed.

This document is a 510(k) clearance letter for the MAGNATEK 40 Hand Held Pulse Oximeter (model MTEK-40). It primarily concerns the regulatory approval of the device and does not contain detailed information about specific acceptance criteria, study methodologies, or performance statistics typically found in a clinical study report.

Therefore, I cannot provide the requested information. The document focuses on confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing its market entry, rather than detailing its performance against specific acceptance criteria.

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