Federal Register: FDA Reclassifies Owlet Baby Care Health Monitor as Over-the-Counter Device
October 09, 2026
October 09, 2026
WASHINGTON, Oct. 9 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register.
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Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use
The Food and Drug Administration (FDA) is classifying the infant pulse rate and oxygen saturation monitor for over-the-counter use into class II. The special . . .
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Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use
The Food and Drug Administration (FDA) is classifying the infant pulse rate and oxygen saturation monitor for over-the-counter use into class II. The special . . .