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Owlet receives FDA clearance for prescription pulse oximetry baby sock

Clearance of the new system settles a controversy that began last year when Owl sold a similar pulse oximetry device over the counter, but was ordered to pull it from sale and seek regulatory approval as a medical device.

The provided link directs to an article on MedTech Dive, which highlights Owlet’s achievement of receiving FDA clearance for their prescription pulse oximetry baby sock. This innovative device is designed to monitor a baby’s oxygen levels and heart rate, providing crucial information to parents and healthcare professionals. The FDA clearance signifies that the product has met the necessary regulatory standards for safety and effectiveness.

Owlet’s prescription pulse oximetry baby sock utilizes advanced technology to track a baby’s vital signs, offering peace of mind to parents concerned about their child’s health. The device is intended for use under the guidance of a healthcare professional, ensuring proper monitoring and interpretation of the data.

By obtaining FDA clearance, Owlet has demonstrated the sock’s adherence to rigorous quality and safety standards. This achievement enhances the company’s credibility and positions them as a trusted provider of baby monitoring technology.

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