NxStage System One Plus
K-Number: K170469 · 2017-05-09
ApplicantNxstage Medical, Inc.
Decision Date2017-05-09
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
NxStage System One Plus is a medical device manufactured by Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2017-05-09 under approval number K170469. 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 Plus?
NxStage System One Plus is a medical device that received FDA 510(k) clearance on 2017-05-09. It is manufactured by Nxstage Medical, Inc.. The 510(k) number is K170469.
When was NxStage System One Plus approved by the FDA?
NxStage System One Plus received FDA 510(k) clearance on 2017-05-09, under approval number K170469.
What company makes NxStage System One Plus?
NxStage System One Plus is manufactured by Nxstage Medical, Inc..
What is the FDA product code for NxStage System One Plus?
The FDA product code for NxStage System One Plus 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.