Optiflux Enexa F500 Dialyzer
K-Number: K192928 · 2020-07-09
Decision Date2020-07-09
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Optiflux Enexa F500 Dialyzer is a medical device manufactured by Fresenius Medical Care Reanal Therapies Group, LLC. It received FDA 510(k) clearance on 2020-07-09 under approval number K192928. 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 Enexa F500 Dialyzer?
Optiflux Enexa F500 Dialyzer is a medical device that received FDA 510(k) clearance on 2020-07-09. It is manufactured by Fresenius Medical Care Reanal Therapies Group, LLC. The 510(k) number is K192928.
When was Optiflux Enexa F500 Dialyzer approved by the FDA?
Optiflux Enexa F500 Dialyzer received FDA 510(k) clearance on 2020-07-09, under approval number K192928.
What company makes Optiflux Enexa F500 Dialyzer?
Optiflux Enexa F500 Dialyzer is manufactured by Fresenius Medical Care Reanal Therapies Group, LLC.
What is the FDA product code for Optiflux Enexa F500 Dialyzer?
The FDA product code for Optiflux Enexa F500 Dialyzer 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.