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510(k) K153518

Medipure Oxygen-LC System by Praxair Distribution, Incorporated. — Product Code ECX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2016
Date Received
December 8, 2015
Clearance Type
Special
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

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  • 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)