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510(k) K181991

NxStage Connected Health System by Nxstage Medical, Inc. — Product Code FKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2018
Date Received
July 26, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Single Patient
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Nxstage Medical, Inc.

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  • K230632 — VersiHD with GuideMe software (August 11, 2023)
  • K183158 — NxStage Cartridge Express with Speedswap (August 9, 2019)
  • K171331 — NxStage System One (August 24, 2017)
  • K170469 — NxStage System One Plus (May 9, 2017)
  • K150472 — NxStage System One (June 4, 2015)
  • K143313 — NxStage Therapeutic Plasma Exchange (TPE) Cartridge (March 20, 2015)
  • K141752 — NXSTAGE SYSTEM ONE (December 19, 2014)
  • K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECT (September 11, 2014)

Other clearances for product code FKP

  • K131739 — NXSTAGE CONNECTED HEALTH SYSTEM (October 10, 2013)
  • K130460 — NXSTAGE DOSING CALCULATOR (July 11, 2013)
  • K040074 — ONEVIEW INTERFACE (April 8, 2004)
  • K021060 — FRESENIUS ICARE MONITORING SYSTEM (November 13, 2002)
  • K003615 — STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS (February 1, 2001)
  • K992255 — CKHEMO, MODEL CKHEMO VERSION 1.0 (November 30, 1999)
  • K964264 — HIGH RANGE PEROXIDE TEST STRIP (June 16, 1997)
  • K955423 — PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM (June 13, 1996)
  • K953854 — WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE (March 11, 1996)
  • K930181 — BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE (November 29, 1995)