FDA 510(k) Applications for Medical Device Product Code "FKR"
(Subsystem, Proportioning)

FDA 510(k) Number Applicant Device Name Decision Date
K060296 NXSTAGE MEDICAL, INC. NXSTAGE DIALYSATE PREPARATION MODULE 03/31/2006
K043436 NXSTAGE MEDICAL, INC. NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 03/17/2005
K140571 NXSTAGE MEDICAL, INC. NXSTAGE PUREFLOW SL 05/15/2014
K080919 NXSTAGE MEDICAL, INC. NXSTAGE PUREFLOW SL 10/15/2008
K111174 NXSTAGE MEDICAL, INC. NXSTAGE PUREFLOW SL 09/19/2011


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