2008K2 Hemodialysis Machine
K-Number: K153449 · 2016-04-26
Decision Date2016-04-26
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
2008K2 Hemodialysis Machine is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2016-04-26 under approval number K153449. 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 2008K2 Hemodialysis Machine?
2008K2 Hemodialysis Machine is a medical device that received FDA 510(k) clearance on 2016-04-26. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K153449.
When was 2008K2 Hemodialysis Machine approved by the FDA?
2008K2 Hemodialysis Machine received FDA 510(k) clearance on 2016-04-26, under approval number K153449.
What company makes 2008K2 Hemodialysis Machine?
2008K2 Hemodialysis Machine is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.
What is the FDA product code for 2008K2 Hemodialysis Machine?
The FDA product code for 2008K2 Hemodialysis Machine is KDI.
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Related Devices (Code: KDI)
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.