Acumen Hypotension Prediction Index (HPI) Algorithm— 510(k) K230057
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K230057 for Acumen Hypotension Prediction Index (HPI) Algorithm, Substantially Equivalent on 2023-06-08. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code QAQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code QAQ
view all- K242518 — Hypertension Prediction Index (HePI) Algorithm
- K203224 — Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
- K183646 — Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure
- DEN160044 — Acumen Hypotension Prediction Index (HPI) Feature Software
More clearances from Edwards Lifesciences, LLC
view allData sourced from openFDA. This site is unofficial and independent of the FDA.