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510(k) K862716

HEMOFILTRATION SYSTEM 10 by Gambro, Inc. — Product Code FII

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1986
Date Received
July 17, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Dialysate Delivery, Sealed
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Gambro, Inc.

  • K083158 — EXALIS, SOFTWARE VERSION 1.15 (June 5, 2009)
  • K072093 — PRISMAFLEX SYSTEM, VERSION 3.20 (February 1, 2008)
  • K070643 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35 (November 2, 2007)
  • K032431 — PRISMA M60/M100 SETS (September 15, 2003)
  • K896758 — GAMBRO BICARBONATE MONITOR BCM 10-3 (September 28, 1990)
  • K896757 — GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS (August 30, 1990)
  • K902481 — GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER (July 27, 1990)
  • K900918 — GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER (July 16, 1990)
  • K892523 — GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY (May 11, 1989)
  • K890112 — ENGSTROM ELIZA + CO2 ANALYZER (March 15, 1989)

Other clearances for product code FII

  • K030470 — NXSTAGE SYSTEM ONE (July 7, 2003)
  • K881270 — GAMBRO MULTIPURPOSE SYSTEM MPS-10 (August 24, 1988)
  • K872364 — HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 (October 13, 1987)
  • K822386 — COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA (October 6, 1982)