The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Hemosphere Advanced Monitor Viewfinder Remote, Hemosphere Technology Module, Hemosphere Foresight Oximeter Cable, Acumen Hypotension Prediction Index Software Feature, Acumen Assisted Fluid Management Software Feature With Acumen Afm Cable.
| Device ID | K213682 |
| 510k Number | K213682 |
| Device Name: | HemoSphere Advanced Monitor Viewfinder Remote, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Software Feature, Acumen Assisted Fluid Management Software Feature With Acumen AFM Cable |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Manthan Damani |
| Correspondent | Manthan Damani Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Product Code | DQK |
| Subsequent Product Code | DQE |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DXN |
| Subsequent Product Code | MUD |
| Subsequent Product Code | QAQ |
| Subsequent Product Code | QMS |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-22 |
| Decision Date | 2022-06-22 |