510(k) DEN190029
DEN190029 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences for the device "Acumen Assisted Fluid Management (AFM) Software Feature". The FDA issued a decision of De Novo Granted on November 13, 2020. The device falls under product code QMS (Adjunctive Open Loop Fluid Therapy Recommender), a Class II device regulated under 21 CFR 870.5600. Edwards Lifesciences has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- November 13, 2020
- Date Received
- June 3, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adjunctive Open Loop Fluid Therapy Recommender
- Device Class
- Class II
- Regulation Number
- 870.5600
- Review Panel
- CV
- Submission Type
The adjunctive open loop fluid therapy recommender is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict a patients estimated response to fluid therapy. The device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.