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510(k) K142149

OXYTOTE INFINITY SERIES VIPR SYSTEMS by Western/Scott Fetzer Co. — Product Code ECX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2015
Date Received
August 5, 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

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  • K143060 — Intelli-Ox (May 21, 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)