Home / 510(k) Clearances / K101792

510(k) K101792

LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 by Linde Gas North America, LLC — Product Code ECX

K101792 is an FDA 510(k) premarket notification submitted by Linde Gas North America, LLC for the device "LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706". The FDA issued a decision of Substantially Equivalent on March 18, 2011. 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
March 18, 2011
Date Received
June 28, 2010
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)
  • K143060 — Intelli-Ox (May 21, 2015)
  • 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)
  • 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