Birdwatch Note Rating
2024-02-26 21:26:21 UTC - HELPFUL
Rated by Participant: E9A9F6E6F02B47E81CBE8B274DA875EBDEE4B63EAE3E026FA240DD7C4DD850E3
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