Dream Sock— 510(k) DEN220091
UnknownOwlet Babycare, Inc.
FDA 510(k) clearance DEN220091 for Dream Sock, Unknown on 2023-11-08. Applicant: Owlet Babycare, Inc.. Device class: 2.
Clearance details
- Applicant
- Owlet Babycare, Inc.
- Product code
- Code QYU
- Device class
- Class 2
- Regulation
- 21 CFR 870.2705
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Lehi, UT, US
Recent devices under product code QYU
view allMore clearances from Owlet Babycare, Inc.
view allAdverse events under product code QYU
product code QYU- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.