NxStage System One
K-Number: K171331 · 2017-08-24
ApplicantNxstage Medical, Inc.
Decision Date2017-08-24
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
NxStage System One is a medical device manufactured by Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2017-08-24 under approval number K171331. 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 NxStage System One?
NxStage System One is a medical device that received FDA 510(k) clearance on 2017-08-24. It is manufactured by Nxstage Medical, Inc.. The 510(k) number is K171331.
When was NxStage System One approved by the FDA?
NxStage System One received FDA 510(k) clearance on 2017-08-24, under approval number K171331.
What company makes NxStage System One?
NxStage System One is manufactured by Nxstage Medical, Inc..
What is the FDA product code for NxStage System One?
The FDA product code for NxStage System One 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.