510(k) K233984
- Device
- Acumen Assisted Fluid Management (AFM) Software Feature
- Applicant
- Edwards Lifesciences, LLC
- 510(k) number
- K233984
- Product code
- QMS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-08-02
- Date received
- 2023-12-18
- Regulation
- 870.5600
- Classification name
- Adjunctive Open Loop Fluid Therapy Recommender
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kshama Pai
- Address
- One Edwards Way Irvine CA US 92614 92614
FDA Registration Numbers#
- 3006082230
- 2648045
- 1018233
- 3013596024
- 9615817
- 3013500228
- 2015691
- 3004832480
- 3037724692
- 3032916632
- 2133641
Source Documents#
Other 510(k) Records For Product Code QMS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN190029 | Acumen Assisted Fluid Management (AFM) Software Feature | Edwards Lifesciences | 2020-11-13 |