FDA Product Code
FDA Product Code QYU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2705
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K234021 | Masimo Stork | Masimo Corporation | 2024-05-03 | Traditional | PDF ↗ |
| DEN220091 | Dream Sock | Owlet Babycare, Inc. | 2023-11-08 | Direct | — |
Product code QYU · Class II · Cardiovascular. Data: openFDA.