5008X Hemodialysis System
K-Number: K231534 · 2024-02-02
ApplicantFresenius Medical Care
Decision Date2024-02-02
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
5008X Hemodialysis System is a medical device manufactured by Fresenius Medical Care. It received FDA 510(k) clearance on 2024-02-02 under approval number K231534. 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 5008X Hemodialysis System?
5008X Hemodialysis System is a medical device that received FDA 510(k) clearance on 2024-02-02. It is manufactured by Fresenius Medical Care. The 510(k) number is K231534.
When was 5008X Hemodialysis System approved by the FDA?
5008X Hemodialysis System received FDA 510(k) clearance on 2024-02-02, under approval number K231534.
What company makes 5008X Hemodialysis System?
5008X Hemodialysis System is manufactured by Fresenius Medical Care.
What is the FDA product code for 5008X Hemodialysis System?
The FDA product code for 5008X Hemodialysis System 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.