Owlet Babycare, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Owlet Babycare, Inc. - FDA 510(k) Cleared Devices
Recent clearances: BabySat 3
2
Total
1
Cleared
1
Denied
Owlet Babycare, Inc. has 1 FDA 510(k) cleared medical devices. Based in Lehi, US.
Last cleared in 2023. Active since 2023. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Owlet Babycare, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by ProMedic Consulting, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Owlet Babycare, Inc.
2 devices