Acumen Assisted Fluid Management (AFM) Software Feature— 510(k) K233984
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K233984 for Acumen Assisted Fluid Management (AFM) Software Feature, Substantially Equivalent on 2024-08-02. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code QMS
- Device class
- Class 2
- Regulation
- 21 CFR 870.5600
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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