Optiflux Series of Dialyzers F160NR, F180NR, F200NR
K-Number: K203062 · 2020-12-28
Decision Date2020-12-28
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Optiflux Series of Dialyzers F160NR, F180NR, F200NR is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2020-12-28 under approval number K203062. 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 Series of Dialyzers F160NR, F180NR, F200NR?
Optiflux Series of Dialyzers F160NR, F180NR, F200NR is a medical device that received FDA 510(k) clearance on 2020-12-28. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K203062.
When was Optiflux Series of Dialyzers F160NR, F180NR, F200NR approved by the FDA?
Optiflux Series of Dialyzers F160NR, F180NR, F200NR received FDA 510(k) clearance on 2020-12-28, under approval number K203062.
What company makes Optiflux Series of Dialyzers F160NR, F180NR, F200NR?
Optiflux Series of Dialyzers F160NR, F180NR, F200NR is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.
What is the FDA product code for Optiflux Series of Dialyzers F160NR, F180NR, F200NR?
The FDA product code for Optiflux Series of Dialyzers F160NR, F180NR, F200NR is KDI.
Other Devices by Fresenius Medical Care Renal Therapies Group, LLC
Related Devices (Code: KDI)
K160558RAPIDO HOLLOW-FIBRE DIALYZERSBellco Srl
K160881Tablo ConsoleOutset Medical, Inc.
K1534492008K2 Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC
K152938DBB-06 Hemodialysis Delivery SystemNIKKISO CO., LTD.
K143482xevonta dialyzerB. Braun Avitum AG
K170790SAM CRRT Unit, SAM Cassette CRRTSpectral Medical, Inc.
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.