FDA Product Code
FDA Product Code QFJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1345
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230273 | Saranas Early Bird Bleed Monitoring System | Saranas, Inc. | 2023-05-25 | Traditional | PDF ↗ |
| DEN180021 | Early Bird Bleed Monitoring System | Saranas, Inc. | 2019-03-01 | Direct | — |
Product code QFJ · Class II · Cardiovascular. Data: openFDA.