The following data is part of a premarket notification filed by Edwards Lifeciences, Llc with the FDA for Acumen Hypotension Prediction Index – Ev1000 Clinical Platform, Acumen Hypotension Prediction Index – Hemosphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – Hemosphere Advanced Monitoring Platform - Pressure.
| Device ID | K183646 |
| 510k Number | K183646 |
| Device Name: | Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure |
| Classification | Adjunctive Predictive Cardiovascular Indicator |
| Applicant | Edwards Lifeciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Lisa Gilman |
| Correspondent | Lisa Gilman Edwards Lifeciences, 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 | 2018-12-26 |
| Decision Date | 2019-05-21 |