NxStage Cartridge Express with Speedswap
K-Number: K183158 · 2019-08-09
ApplicantNxstage Medical, Inc.
Decision Date2019-08-09
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
NxStage Cartridge Express with Speedswap is a medical device manufactured by Nxstage Medical, Inc.. It received FDA 510(k) clearance on 2019-08-09 under approval number K183158. 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 Cartridge Express with Speedswap?
NxStage Cartridge Express with Speedswap is a medical device that received FDA 510(k) clearance on 2019-08-09. It is manufactured by Nxstage Medical, Inc.. The 510(k) number is K183158.
When was NxStage Cartridge Express with Speedswap approved by the FDA?
NxStage Cartridge Express with Speedswap received FDA 510(k) clearance on 2019-08-09, under approval number K183158.
What company makes NxStage Cartridge Express with Speedswap?
NxStage Cartridge Express with Speedswap is manufactured by Nxstage Medical, Inc..
What is the FDA product code for NxStage Cartridge Express with Speedswap?
The FDA product code for NxStage Cartridge Express with Speedswap 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.