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510(k) K033897

MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM by Aga-Linde Health Care — Product Code ECX

K033897 is an FDA 510(k) premarket notification submitted by Aga-Linde Health Care for the device "MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on July 19, 2004. 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
July 19, 2004
Date Received
December 16, 2003
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)
  • 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)

FDA data resources