Owlet Announces De Novo FDA Clearance For Dream Sock - Quick Facts

(RTTNews) - Owlet, Inc. (OWLT) announced De Novo clearance from the FDA of Dream Sock, the first and only over-the-counter medical pulse oximetry solution for infants. The Dream Sock will monitor and display Baby's Live Health Readings, including pulse rate and oxygen saturation level, and will provide Health Notifications, which will alert caregivers with lights and alarm sounds if infant's readings fall outside of preset ranges.

The company noted that achieving De Novo clearance means the Owlet Dream Sock was clinically tested in both home and hospital environments, and proven to be as accurate as medical-grade baby monitoring technology and compliant with all relevant performance and safety standards by independent laboratories.

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