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510(k) K071581

BACKPACK MEDICAL OXYGEN SYSTEM by Essex Cryogenics of Missouri, Inc. — Product Code BYJ

K071581 is an FDA 510(k) premarket notification submitted by Essex Cryogenics of Missouri, Inc. for the device "BACKPACK MEDICAL OXYGEN SYSTEM". The FDA issued a decision of Substantially Equivalent on July 11, 2007. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. Essex Cryogenics of Missouri, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2007
Date Received
June 8, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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)
  • K033000 — NEXT GENERATION PORTABLE THERAPEUTIC LIQUID OXYGEN SYSTEM (March 22, 2004)
  • 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)
  • K050153 — SPIRIT, MODEL HAS (April 15, 2005)
  • K050414 — PLIX (April 11, 2005)

FDA data resources