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Medical Devices / Submissions and Approvals

FDA Clears Masimo’s CO-Oximeter

March 26, 2019
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Masimo received 510(k) clearance for its Rad-67 Pulse CO-Oximeter, a device used to measure the oxygen carrying state of hemoglobin in a blood sample.

The portable device performs spot-check monitoring using its DCI-mini sensor, which analyzes total hemoglobin, carboxyhemoglobin, methemoglobin and arterial oxygen saturation.

The single-device solution is suited for use in both clinical and non-clinical settings, such as emergency rooms, physician’s offices and pre- and post-surgery situations.

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