HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index— 510(k) K203687

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K203687 for HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index, Substantially Equivalent on 2021-05-28. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2020-12-17
Decision date: 2021-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.