The following data is part of a premarket notification filed by Air Liquide Healthcare America Corporation with the FDA for Intelli-ox.
Device ID | K161179 |
510k Number | K161179 |
Device Name: | Intelli-Ox |
Classification | Cylinder, Compressed Gas, And Valve |
Applicant | AIR LIQUIDE HEALTHCARE AMERICA CORPORATION 12800 West Little York Road Houston, TX 77041 -2280 |
Contact | Steve Miller |
Correspondent | Steve Miller AIR LIQUIDE HEALTHCARE AMERICA CORPORATION 12800 West Little York Road Houston, TX 77041 -2280 |
Product Code | ECX |
CFR Regulation Number | 868.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-04-26 |
Decision Date | 2017-04-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INTELLI-OX 86263930 5078340 Live/Registered |
Air Liquide Healthcare America Corporation 2014-04-27 |
INTELLI-OX 77794658 not registered Dead/Abandoned |
Air Liquide Healthcare America Corporation 2009-07-31 |