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Medical Devices / Submissions and Approvals

Nonin Medical's Finger Pulse Oximeter Clears FDA Hurdle

Sept. 2, 2014
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Minneapolis, Minn.-based Nonin Medical got the FDA’s go-ahead to market its Model 3231 finger pulse oximeter in the U.S. The device measures oxygen saturation and pulse rate when placed on a patient’s finger.

The Model 3231, which features Nonin’s PureSAT technology, can be used on a wide patient population, from children to adults, the company said in announcing the 510(k) clearance Thursday. The oximeter plugs into a telemedicine hub or kiosk via a USB cord.

PureSAT uses intelligent pulse-by-pulse filtering to provide accurate oximetry measurements regardless of motion, dark skin tones, low perfusion, rapid SpO2 changes and other challenging conditions, the company says. The device also sends an alert through a digital display if the patient’s finger is not properly placed — preventing incorrect readings — and automatically determines when a measurement is ready to be stored.

The Model 3231 oximeter was CE-marked last year. A wireless version of the device received FDA clearance last September. — Kellen Owings

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