Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform— 510(k) K203224
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K203224 for Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform, Substantially Equivalent on 2021-07-30. 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.