Edwards Lifesciences, LLC · Class II · Cleared Nov 22, 2022
| K-number | K221704 |
| Device name | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) |
| Applicant | Edwards Lifesciences, LLC |
| Product code | DQK |
| Device class | Class II |
| Decision date | Nov 22, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
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