Acumen Assisted Fluid Management (AFM) Software Feature— 510(k) DEN190029
UnknownEdwards Lifesciences
FDA 510(k) clearance DEN190029 for Acumen Assisted Fluid Management (AFM) Software Feature, Unknown on 2020-11-13. Applicant: Edwards Lifesciences. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences
- Product code
- Code QMS
- Device class
- Class 2
- Regulation
- 21 CFR 870.5600
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Irvine, CA, US
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