Birdwatch Note Rating
2024-02-26 21:03:31 UTC - HELPFUL
Rated by Participant: A8FCBBAE1CE511533D639828D3A86C900654B72B2FAE8FB42CD6C5E65F50A395
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