Owlet Seeks 510(k) Clearance for Infant Oximeter
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.