FDA 510(k), K181991, NxStage Connected Health System

FDA 510(k), K181991, NxStage Connected Health System

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510(K) Number: K181991
Device Name: NxStage Connected Health System
Manufacturer: Christina Marabella
Device Classification Name: System, Dialysate Delivery, Single Patient
Regulation Number: FKP
Classification Product Code: 07/26/2018
Date Received: 09/26/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology

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