FDA 510(k)

HDF Assist Mudule, HDF Infusion Set and Substitution Filter

Numéro K : K210575 · 2022-05-13

Date de décision2022-05-13

Code produitKDI

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

HDF Assist Mudule, HDF Infusion Set and Substitution Filter is the device name listed in this FDA 510(k) record. The listed applicant is Nephros. It received FDA 510(k) clearance on 2022-05-13 under 510(k) number K210575. 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 HDF Assist Mudule, HDF Infusion Set and Substitution Filter?

HDF Assist Mudule, HDF Infusion Set and Substitution Filter is a medical device that received FDA 510(k) clearance on 2022-05-13. The listed applicant is Nephros. The 510(k) number is K210575.

When did HDF Assist Mudule, HDF Infusion Set and Substitution Filter receive FDA 510(k) clearance?

HDF Assist Mudule, HDF Infusion Set and Substitution Filter received FDA 510(k) clearance on 2022-05-13, under 510(k) number K210575.

Who is the listed applicant for HDF Assist Mudule, HDF Infusion Set and Substitution Filter?

The FDA 510(k) record lists Nephros as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDF Assist Mudule, HDF Infusion Set and Substitution Filter?

The FDA product code for HDF Assist Mudule, HDF Infusion Set and Substitution Filter is KDI.

Essais cliniques associés

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Dispositifs connexes (Code : KDI)

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Source officielle

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