Home / 510(k) Clearances / K033000

510(k) K033000

NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM by Essex Cryogenics of Missouri, Inc. — Product Code BYJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2004
Date Received
September 25, 2003
Clearance Type
Traditional
Expedited Review
Yes
Third Party Review
No

Device Classification

Device Name
Unit, Liquid-Oxygen, Portable
Device Class
Class II
Regulation Number
868.5655
Review Panel
AN
Submission Type

Other clearances by Essex Cryogenics of Missouri, Inc.

  • K131990 — OXYGEN GENERATOR LIQUEFIER - (OGL) (February 21, 2014)
  • K071581 — BACKPACK MEDICAL OXYGEN SYSTEM (July 11, 2007)
  • K022684 — PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS) (September 11, 2002)
  • K880183 — PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT (April 14, 1988)

Other clearances for product code BYJ

  • K130068 — DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) (July 19, 2013)
  • K113767 — MOUNTED MEDICAL OXYGEN SYSTEM (June 29, 2012)
  • K103324 — PRECISION LIQUID OXYGEN SYSTEM (April 21, 2011)
  • K101272 — MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 (August 20, 2010)
  • K081779 — GOLOX-93 (September 19, 2008)
  • K080023 — MODIFICATION TO: SPIRIT (June 16, 2008)
  • K072723 — RESPIRONICS GOLOX (March 20, 2008)
  • K072011 — COPD LIQUID OXYGEN PORTABLE, MODEL 300P (October 18, 2007)
  • K071581 — BACKPACK MEDICAL OXYGEN SYSTEM (July 11, 2007)
  • K050153 — SPIRIT, MODEL HAS (April 15, 2005)