FDA 510(k)

Optiflux Enexa F500 Dialyzer

Numéro K : K192928 · 2020-07-09

DemandeurFresenius Medical Care Reanal Therapies Group, LLC

Date de décision2020-07-09

Code produitKDI

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

Optiflux Enexa F500 Dialyzer is the device name listed in this FDA 510(k) record. The listed applicant is Fresenius Medical Care Reanal Therapies Group, LLC. It received FDA 510(k) clearance on 2020-07-09 under 510(k) number K192928. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Fresenius Medical Care Reanal Therapies Group, LLC. The 510(k) number is K192928.

When did Optiflux Enexa F500 Dialyzer receive FDA 510(k) clearance?

Optiflux Enexa F500 Dialyzer received FDA 510(k) clearance on 2020-07-09, under 510(k) number K192928.

Who is the listed applicant for Optiflux Enexa F500 Dialyzer?

The FDA 510(k) record lists Fresenius Medical Care Reanal Therapies Group, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optiflux Enexa F500 Dialyzer?

The FDA product code for Optiflux Enexa F500 Dialyzer is KDI.

Essais cliniques associés

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Dispositifs connexes (Code : KDI)

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Source officielle

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