AquaBplus; AquaB LITE
K-Number: K232953 · 2024-06-13
Decision Date2024-06-13
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
AquaBplus; AquaB LITE is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2024-06-13 under approval number K232953. 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 AquaBplus; AquaB LITE?
AquaBplus; AquaB LITE is a medical device that received FDA 510(k) clearance on 2024-06-13. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K232953.
When was AquaBplus; AquaB LITE approved by the FDA?
AquaBplus; AquaB LITE received FDA 510(k) clearance on 2024-06-13, under approval number K232953.
What company makes AquaBplus; AquaB LITE?
AquaBplus; AquaB LITE is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.
What is the FDA product code for AquaBplus; AquaB LITE?
The FDA product code for AquaBplus; AquaB LITE is FIP.
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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.