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# FDA De Novo for Owlet Dream Sock
- URL: https://www.fdaweb.com/fda-de-novo-for-owlet-dream-sock/
- Published: 2023-11-10T12:00:00.000Z
- Updated: 2026-09-14T14:15:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155772

FDA has granted Owlet a *de novo* marketing authorization for its Dream Sock, an over-the-counter medical pulse oximetry device for infants. It is designed, Owlet says, to monitor and display a baby’s “Live Health Readings,” including pulse rate and oxygen saturation level, and to provide health notifications to alert caregivers with lights and alarm sounds if their infant’s readings fall outside of preset ranges. Dream Sock is intended for use with healthy infants aged 1-18 months and 6 lbs to 30 lbs.