Home / 510(k) Clearances / K760725

510(k) K760725

COIL MACHINE ADAPTER by Gambro, Inc. — Product Code FLC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1976
Date Received
September 27, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Station, Dialysis Control, Negative Pressure Type
Device Class
Class II
Regulation Number
876.5820
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 FLC

  • K910656 — WILSON-COOK DISPOSABLE BIOPSY FORCEPS (April 25, 1991)
  • K855001 — FRESENIUS HEMODIALYSIS MACHINE A1008 BSM (January 21, 1986)
  • K791164 — NEGATOVE PRESSURE CONVERTOR (October 4, 1979)