Birdwatch Note Rating
2024-04-14 16:04:09 UTC - HELPFUL
Rated by Participant: 6B293C0CA30B12D4CE8363C2DBE85F598F5CECF9F90EBA5AB75D825339F04A4C
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