Edwards Lifesciences, LLC · Class II · Cleared Jun 22, 2022
| K-number | K213682 |
| Device name | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote |
| Applicant | Edwards Lifesciences, LLC |
| Product code | DQK |
| Device class | Class II |
| Decision date | Jun 22, 2022 |
| Decision | Substantially Equivalent |
| Regulation | 870.1425 |
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