Birdwatch Note Rating
2024-02-26 20:41:08 UTC - NOT_HELPFUL
Rated by Participant: 5791971C63D07C577637AA5F134B4172F757AD504D4E2C608AE1BD0564379B73
Participant Details
Original Note:
Owlet, the company being referred to, was warned by the FDA that they were marketing a medical device without being approved as a medical device. They pulled the product voluntarily to avoid fines. In 2023 they were approved by the FDA. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/owlet-baby-care-inc-616354-10052021 https://owletcare.com/pages/fda-response
All Note Details