Subject: FDA
Owlet Submits for FDA Clearance on Owlet Smart Sock
LEHI, Utah, Jan. 23, 2017 /PRNewswire/ -- Owlet Baby Care has submitted a 510(k) to the U.S. Food and Drug Administration (FDA), seeking clearance for a medical version of the Owlet Smart Sock. The application is now pending review. Owlet shared its third-party accuracy validation testing to the FDA as part of its application.
Using technology called pulse oximetry, the Owlet Smart Sock is designed to send notifications to a Base Station and then via Wi-Fi to a parents' smartphone, if a baby's heart rate or oxygen fall outside a preset range. The Owlet is designed for infants up to 18 months old.
FDA clearance on a medical version of the Owlet Smart Sock could provide the opportunity to expand use into the medical space.
ABOUT OWLET BABY CARE
Owlet Baby Care was founded in 2013 by a team of passionate parents who wanted to bring themselves and other parents around the globe peace of mind and assurance by developing a monitor that tracks a baby's oxygen and heart rate. Using clinically proven technology called pulse oximetry, the Owlet Smart Sock is designed to send notifications to the Base Station and via Wi-Fi to a smartphone, if a baby's heart rate or oxygen fall outside a preset range.
SOURCE Owlet Baby Care, Inc.
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