Home / 510(k) Clearances / K915154

510(k) K915154

GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS by C.G.H. Medical, Inc. — Product Code CAN

K915154 is an FDA 510(k) premarket notification submitted by C.G.H. Medical, Inc. for the device "GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS". The FDA issued a decision of Substantially Equivalent on May 27, 1992. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. C.G.H. Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1992
Date Received
November 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Pressure, Gas Cylinder
Device Class
Class I
Regulation Number
868.2700
Review Panel
AN
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)
  • K940601 — GAMBRO BICART 720G (March 22, 1994)
  • 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 CAN

  • K162811 — MR Conditional CGA 870 (March 2, 2017)
  • K080243 — PORTABLE OXYGEN UNIT SCA900 (April 7, 2009)
  • K060265 — REMCORE REMOTE CONTROLLED OXYGEN REGULATOR (October 25, 2006)
  • K061785 — CYL-FIL OXYGEN SYSTEM (September 7, 2006)
  • K950777 — OXYGEN REGULATOR (April 14, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)
  • K936187 — LSPI PRESSURE REGULATOR (January 27, 1994)
  • K932006 — 1500 SERIES REGULATOR (October 25, 1993)
  • K921125 — AMBU OXYGEN REGULATOR (September 17, 1992)
  • K915505 — REGULATOR FLOWMETER (April 22, 1992)

FDA data resources