Owlet Seeks 510(k) Clearance for Infant Oximeter

October 10, 2022

Owlet has submitted a 510(k) premarket notification to the FDA for a new pulse oximetry monitoring device for infants.

The prescription device is intended for home monitoring of babies who are under a physician’s care.

The monitor provides alerts to caregivers when the baby’s heart rate or oxygen saturation level are outside the prescribed ranges.

Lehi, Utah-based Owlet is focused on developing a digital parenting platform that gives real-time data insights to parents.

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