K233984
- 510(k) number
- K233984
- Device name
- Acumen Assisted Fluid Management (AFM) Software Feature
- Applicant
- Edwards Lifesciences, LLC CA · US
- Product code
- QMS — Adjunctive Open Loop Fluid Therapy Recommender
- Decision date
- 2024-08-02
- Date received
- 2023-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K233984.pdf
Official FDA record: K233984
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.