multiFlux 1000 (F00012408)
K-Number: K240394 · 2024-05-31
Decision Date2024-05-31
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
multiFlux 1000 (F00012408) is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2024-05-31 under approval number K240394. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the multiFlux 1000 (F00012408)?
multiFlux 1000 (F00012408) is a medical device that received FDA 510(k) clearance on 2024-05-31. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K240394.
When was multiFlux 1000 (F00012408) approved by the FDA?
multiFlux 1000 (F00012408) received FDA 510(k) clearance on 2024-05-31, under approval number K240394.
What company makes multiFlux 1000 (F00012408)?
multiFlux 1000 (F00012408) is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.
What is the FDA product code for multiFlux 1000 (F00012408)?
The FDA product code for multiFlux 1000 (F00012408) is KDI.
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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.