Home / 510(k) Clearances / K981085

510(k) K981085

GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM by Gambro Healthcare — Product Code FIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1998
Date Received
March 25, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Subsystem, Water Purification
Device Class
Class II
Regulation Number
876.5665
Review Panel
GU
Submission Type

Other clearances by Gambro Healthcare

  • K994390 — GAMBRO POLYFLUX 17R, CAPILLARY DIALYZER/ FILTER (October 26, 2000)
  • K990039 — GAMBRO DQM 200 (January 27, 2000)
  • K982413 — COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS (April 21, 1999)
  • K982414 — GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS (March 26, 1999)
  • K980386 — HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KI (February 24, 1999)
  • K982760 — COBE C HEMODIALYSIS DELIVERY SYSTEM , COBE CARTRIDGE BLOOD TUBING SET (November 4, 1998)
  • K982818 — HOSPAL TIPSTOP (October 21, 1998)
  • K974899 — GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H (September 23, 1998)
  • K981681 — PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM) (August 11, 1998)
  • K970253 — COBE CENTRYSYSTEM 3 DIALYSIS CONTROL UNIT/COBE CARTRIDGE BLOOD TUBING SET (September 26, 1997)

Other clearances for product code FIP

  • K250471 — AquaC UNO H (November 14, 2025)
  • K251851 — DIASAFEplusUS (F00013010) (October 9, 2025)
  • K252181 — AquaA (September 9, 2025)
  • K250514 — UPT Series Medical RO Water Treatment System (March 17, 2025)
  • K232953 — AquaBplus; AquaB LITE (June 13, 2024)
  • K223479 — AQUAbase nX (August 16, 2023)
  • K231410 — RenaPure Endotoxin Retentive Filter (July 19, 2023)
  • K223656 — AmeriWater MediQA Reverse Osmosis System (MSP3HF) (February 13, 2023)
  • K213507 — AquaA (July 27, 2022)
  • K211035 — U9000 Plus Ultrafilter (October 19, 2021)