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FDA 510(k)

multiFiltratePRO System

K-Number: K220281 · 2022-12-16

Decision Date2022-12-16
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

multiFiltratePRO System is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2022-12-16 under approval number K220281. 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 multiFiltratePRO System?

multiFiltratePRO System is a medical device that received FDA 510(k) clearance on 2022-12-16. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K220281.

When was multiFiltratePRO System approved by the FDA?

multiFiltratePRO System received FDA 510(k) clearance on 2022-12-16, under approval number K220281.

What company makes multiFiltratePRO System?

multiFiltratePRO System is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.

What is the FDA product code for multiFiltratePRO System?

The FDA product code for multiFiltratePRO System is KDI.

Other Devices by Fresenius Medical Care Renal Therapies Group, LLC

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.