Optiflux F180NR Dialyzer
K-Number: K192707 · 2020-09-21
Decision Date2020-09-21
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Optiflux F180NR Dialyzer is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2020-09-21 under approval number K192707. 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 Optiflux F180NR Dialyzer?
Optiflux F180NR Dialyzer is a medical device that received FDA 510(k) clearance on 2020-09-21. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K192707.
When was Optiflux F180NR Dialyzer approved by the FDA?
Optiflux F180NR Dialyzer received FDA 510(k) clearance on 2020-09-21, under approval number K192707.
What company makes Optiflux F180NR Dialyzer?
Optiflux F180NR Dialyzer is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.
What is the FDA product code for Optiflux F180NR Dialyzer?
The FDA product code for Optiflux F180NR Dialyzer is KDI.
Other Devices by Fresenius Medical Care Renal Therapies Group, LLC
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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.