FDA 510(k), K141752, NXSTAGE SYSTEM ONE

FDA 510(k), K141752, NXSTAGE SYSTEM ONE

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510(K) Number: K141752
Device Name: NXSTAGE SYSTEM ONE
Manufacturer:
Device Classification Name: Ultrafiltration-Controlled Nocturnal Dialysate Delivery System
Regulation Number: 876.5860
Classification Product Code: ODN
Date Received: 06/30/2014
Decision Date: 12/19/2014
Regulation Medical Specialty: Gastroenterology/Urology
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