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Medical Devices / Submissions and Approvals

Masimo Gains CE Mark for Respiration Rate Measurement Device

Feb. 16, 2017
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Swiss company, Masimo has received a CE mark for its MightySat Rx fingertip pulse oximeter.

The device measures and displays functional oxygen saturation; pulse rate and perfusion index with the option to add pleth variability index — allowing for automated and continuous monitoring of the respiration rate.

The device is not available in the U.S. as it does not have marketing clearance. — Cynthia Jessup

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