FDA Product Code
FDA Product Code QMS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5600
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences, LLC | 2024-08-02 | Traditional | PDF ↗ |
| DEN190029 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences | 2020-11-13 | Direct | — |
Product code QMS · Class II · Cardiovascular. Data: openFDA.