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510(k) K940601

GAMBRO BICART 720G by C.G.H. Medical, Inc. — Product Code KPO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1994
Date Received
February 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by C.G.H. Medical, Inc.

  • K941708 — COBE CENTRYSYSTEM CS500 DIALYZER (May 12, 1995)
  • K933818 — GAMBRO POLYFLUX II HEMODIALYZERIALYZER HEMODIAFILTER (January 25, 1995)
  • K925522 — CENTRYSYSTEM 3 WITH CHARTS/BP OPTION (September 30, 1994)
  • K920757 — FILTRAL HEMODIALYZERS (August 5, 1994)
  • K931720 — LUNDIA ALPHA 700 HEMODIALYZER (July 7, 1994)
  • K924437 — HEMOSPAL KIT B22 / MULTIFLOW 60 KIT (June 27, 1994)
  • K915154 — GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (May 27, 1992)
  • K914271 — GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) (April 13, 1992)
  • K915504 — GAMBRO LUNDIA ALPHA HEMODIALYZERS (March 6, 1992)
  • K911603 — HEMOSPAL KIT B22 (August 7, 1991)

Other clearances for product code KPO

  • K253462 — NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (January 29, 2026)
  • K252180 — Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bi (September 9, 2025)
  • K243786 — Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bi (April 4, 2025)
  • K240920 — HemoCare Bicarbonate Concentrate Set (BCS) (July 12, 2024)
  • K233950 — pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pu (May 10, 2024)
  • K233213 — NxStage PureFlow Solution (January 18, 2024)
  • K233159 — pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 5 (December 1, 2023)
  • K223431 — Citric Complete Liquid Citric Acid Concentrate (August 4, 2023)
  • K221652 — NIKKICART (March 3, 2023)
  • K202508 — Hemo-Lyte C Cartridge (August 12, 2022)