NxStage Connected Health System
K-Number: K181991 · 2018-09-26
ApplicantNxstage Medical, Inc.
Decision Date2018-09-26
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
NxStage Connected Health System is a medical device manufactured by Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2018-09-26 under approval number K181991. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NxStage Connected Health System?
NxStage Connected Health System is a medical device that received FDA 510(k) clearance on 2018-09-26. It is manufactured by Nxstage Medical, Inc.. The 510(k) number is K181991.
When was NxStage Connected Health System approved by the FDA?
NxStage Connected Health System received FDA 510(k) clearance on 2018-09-26, under approval number K181991.
What company makes NxStage Connected Health System?
NxStage Connected Health System is manufactured by Nxstage Medical, Inc..
What is the FDA product code for NxStage Connected Health System?
The FDA product code for NxStage Connected Health System is FKP.
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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.