Device Listing 1092704160
Listing Summary#
- Listing key
- 1092704160
- Premarket submission
- K213682
- Device
- 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
- Decision date
- 2022-06-22