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510(k) K062300

OX-SOX, MODEL C, D, E, by Pattient Safety Innovations, Llp — Product Code ECX

K062300 is an FDA 510(k) premarket notification submitted by Pattient Safety Innovations, Llp for the device "OX-SOX, MODEL C, D, E,". The FDA issued a decision of Substantially Equivalent on November 27, 2006. 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
November 27, 2006
Date Received
August 8, 2006
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)
  • K053117 — EZ-OX PLUS (April 10, 2006)

FDA data resources