Dream Sock
FDA 510(k) clearance DEN220091 · decided 2023-11-08
Clearance details
- K-number
- DEN220091
- Device name
- Dream Sock
- Applicant
- Owlet Babycare, Inc.
- Decision
- Unknown
- Date received
- 2022-12-14
- Decision date
- 2023-11-08
- Days to decision
- 329 days
- Clearance type
- Direct
- Product code
- QYU
- Device class
- 2
- Regulation number
- 870.2705
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lehi, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Masimo Stork (K234021) | Masimo Corporation | 2024-05-03 |
Recalls involving this device
No recalls on record reference this clearance.