Data / Medical devices / United States / Owlet Baby Care
Owlet Baby Care: FDA-registered device maker in Lehi, UT, United States, 2 510(k) clearances
Owlet Baby Care is registered with the FDA (registration 3012977166) in Lehi, UT, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 8, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012977166
- Address
- 2940 West Maple Loop Dr. Suite 203, Lehi, UT, United States, 84048
- Owner or operator
- Owlet Baby Care, Inc. (10084729)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 29, 2023
- Registered through
- 2027
- Brand names listed
- BabySat 3, Dream Sock
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use | QYU | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 8, 2023 | DEN220091 | Dream Sock | QYU | Unknown | Owlet Babycare, Inc. | accessdata.fda.gov |
| June 16, 2023 | K222597 | BabySat 3 | DQA | Substantially Equivalent | Owlet Babycare, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
Updated November 8, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.