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510(k) K130068

DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) by Essex Industries, Inc. D/B/A Essex Cryogenics of M — Product Code BYJ

K130068 is an FDA 510(k) premarket notification submitted by Essex Industries, Inc. D/B/A Essex Cryogenics of M for the device "DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS)". The FDA issued a decision of Substantially Equivalent on July 19, 2013. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2013
Date Received
January 11, 2013
Clearance Type
Traditional
Expedited Review
No
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 for product code BYJ

  • 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)
  • K050414 — PLIX (April 11, 2005)

FDA data resources