AquaC UNO H
K-Number: K250471 · 2025-11-14
Decision Date2025-11-14
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
AquaC UNO H is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2025-11-14 under approval number K250471. 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 AquaC UNO H?
AquaC UNO H is a medical device that received FDA 510(k) clearance on 2025-11-14. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K250471.
When was AquaC UNO H approved by the FDA?
AquaC UNO H received FDA 510(k) clearance on 2025-11-14, under approval number K250471.
What company makes AquaC UNO H?
AquaC UNO H is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.
What is the FDA product code for AquaC UNO H?
The FDA product code for AquaC UNO H 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.