The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Acumen Hypotension Prediction Index, Hemosphere Advanced Monitoring Platform.
| Device ID | K203224 |
| 510k Number | K203224 |
| Device Name: | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform |
| Classification | Adjunctive Predictive Cardiovascular Indicator |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Lisa Gilman |
| Correspondent | Lisa Gilman Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Product Code | QAQ |
| CFR Regulation Number | 870.2210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-02 |
| Decision Date | 2021-07-30 |