DEN220091
- 510(k) number
- DEN220091
- Device name
- Dream Sock
- Applicant
- Owlet Babycare, Inc. UT · US
- Product code
- QYU — Infant Pulse Rate And Oxygen Saturation Monitor For
- Decision date
- 2023-11-08
- Date received
- 2022-12-14
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Cardiovascular
Official FDA record: DEN220091
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.