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510(k) K113767

MOUNTED MEDICAL OXYGEN SYSTEM by Essex Industries, Inc. — Product Code BYJ

K113767 is an FDA 510(k) premarket notification submitted by Essex Industries, Inc. for the device "MOUNTED MEDICAL OXYGEN SYSTEM". The FDA issued a decision of Substantially Equivalent on June 29, 2012. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. Essex Industries, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2012
Date Received
December 21, 2011
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 Industries, Inc.

  • K162811 — MR Conditional CGA 870 (March 2, 2017)
  • K161472 — Walk-O2-Bout (November 18, 2016)
  • K101272 — MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 (August 20, 2010)

Other clearances for product code BYJ

  • K130068 — DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) (July 19, 2013)
  • 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)
  • K050414 — PLIX (April 11, 2005)

FDA data resources