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510(k) K143060

Intelli-Ox by Air Liquide Healthcare — Product Code ECX

K143060 is an FDA 510(k) premarket notification submitted by Air Liquide Healthcare for the device "Intelli-Ox". The FDA issued a decision of Substantially Equivalent on May 21, 2015. The device falls under product code ECX (Cylinder, Compressed Gas, And Valve), a Class I device regulated under 21 CFR 868.2700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2015
Date Received
October 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cylinder, Compressed Gas, And Valve
Device Class
Class I
Regulation Number
868.2700
Review Panel
AN
Submission Type

Other clearances for product code ECX

  • K161179 — Intelli-Ox (April 13, 2017)
  • K161472 — Walk-O2-Bout (November 18, 2016)
  • K153518 — Medipure Oxygen-LC System (June 3, 2016)
  • K142149 — OXYTOTE INFINITY SERIES VIPR SYSTEMS (April 17, 2015)
  • K132778 — GRAB 'N GO PLUS, GRAB 'N GO DIGITAL (July 7, 2014)
  • K131386 — EZ-OX PLUS GENERATION II (March 14, 2014)
  • K101792 — LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 (March 18, 2011)
  • K063354 — LINDE INTEGRATED VALVE (LIV) (April 17, 2007)
  • K062300 — OX-SOX, MODEL C, D, E, (November 27, 2006)
  • K053117 — EZ-OX PLUS (April 10, 2006)

FDA data resources