AquaA
K-Number: K213507 · 2022-07-27
Decision Date2022-07-27
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
AquaA is a medical device manufactured by Fresenius Medical Care Rental Therapies Group, LLC. It received FDA 510(k) clearance on 2022-07-27 under approval number K213507. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AquaA?
AquaA is a medical device that received FDA 510(k) clearance on 2022-07-27. It is manufactured by Fresenius Medical Care Rental Therapies Group, LLC. The 510(k) number is K213507.
When was AquaA approved by the FDA?
AquaA received FDA 510(k) clearance on 2022-07-27, under approval number K213507.
What company makes AquaA?
AquaA is manufactured by Fresenius Medical Care Rental Therapies Group, LLC.
What is the FDA product code for AquaA?
The FDA product code for AquaA is FIP.
Related Devices (Code: FIP)
K161844Matrix Pre-Treatment ControllerBetter Water, LLC
K153329MED-TECH Water Systems Inc Exchangeable Carbon Tanks for DialysisMed-Tech Water Systems, Inc.
K161304EndoPur FilterNephros, Inc.
K171099EON Portable Reverse Osmosis Water Purification SystemCantel
K192398Millenium HXMar Cor Purification, Inc.
K182367DIASAFEplusUSFresenius Medical Care Renal Therapies Group, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.