DIASAFEplusUS
K-Number: K182367 · 2019-01-10
Decision Date2019-01-10
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
DIASAFEplusUS is a medical device manufactured by Fresenius Medical Care Renal Therapies Group, LLC. It received FDA 510(k) clearance on 2019-01-10 under approval number K182367. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DIASAFEplusUS?
DIASAFEplusUS is a medical device that received FDA 510(k) clearance on 2019-01-10. It is manufactured by Fresenius Medical Care Renal Therapies Group, LLC. The 510(k) number is K182367.
When was DIASAFEplusUS approved by the FDA?
DIASAFEplusUS received FDA 510(k) clearance on 2019-01-10, under approval number K182367.
What company makes DIASAFEplusUS?
DIASAFEplusUS is manufactured by Fresenius Medical Care Renal Therapies Group, LLC.
What is the FDA product code for DIASAFEplusUS?
The FDA product code for DIASAFEplusUS is FIP.
Other Devices by Fresenius Medical Care Renal Therapies Group, LLC
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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.