510(k) DEN220091
- Device
- Dream Sock
- Applicant
- Owlet Babycare, Inc.
- 510(k) number
- DEN220091
- Product code
- QYU
- Decision
- Unknown (DENG)
- Decision date
- 2023-11-08
- Date received
- 2022-12-14
- Regulation
- 870.2705
- Classification name
- Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jim Fidacaro
- Address
- 3300 N. Ashton Blvd., Suite 300 Lehi UT US 84043 84043
FDA Registration Numbers#
- 3003899230
- 3012977166
- 3004415095
- 3019388613
- 3011353843
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QYU#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K234021 | Masimo Stork | Masimo Corporation | 2024-05-03 |