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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Dialysate Delivery, Single Patient
510(k) Number K181991
Device Name NxStage Connected Health System
Applicant
Nxstage Medical, Inc.
350 Merrimack St.
Lawrence,  MA  01843
Applicant Contact Christina Marabella
Correspondent
Nxstage Medical, Inc.
350 Merrimack St.
Lawrence,  MA  01843
Correspondent Contact Christina Marabella
Regulation Number876.5820
Classification Product Code
FKP  
Date Received07/26/2018
Decision Date 09/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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