Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Cylinder, Compressed Gas, And Valve
510(k) Number K153518
Device Name Medipure Oxygen-LC System
Applicant
PRAXAIR DISTRIBUTION, INCORPORATED.
175 EAST PARK DRIVE
TONAWANDA,  NY  14150
Applicant Contact Michael Skrjanc
Correspondent
EMERGO GLOBAL CONSULTING, LLC
816 CONGRESS AVENUE
SUITE 1400
AUSTIN,  TX  78701
Correspondent Contact Audrey Swearingen
Regulation Number868.2700
Classification Product Code
ECX  
Date Received12/08/2015
Decision Date 06/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-