DeviceClearance

Acumen Hypotension Prediction Index (HPI) Algorithm— 510(k) K230057

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K230057 for Acumen Hypotension Prediction Index (HPI) Algorithm, Substantially Equivalent on 2023-06-08. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant
Edwards Lifesciences, LLC
Product code
Code QAQ
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

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