The following data is part of a premarket notification filed by Air Liquide Healthcare America with the FDA for Ez-ox Plus Generation Ii.
Device ID | K131386 |
510k Number | K131386 |
Device Name: | EZ-OX PLUS GENERATION II |
Classification | Cylinder, Compressed Gas, And Valve |
Applicant | AIR LIQUIDE HEALTHCARE AMERICA 2700 POST OAK BLVD. SUITE 1800 Houston, TX 77056 |
Contact | Angie Beyer |
Correspondent | Angie Beyer AIR LIQUIDE HEALTHCARE AMERICA 2700 POST OAK BLVD. SUITE 1800 Houston, TX 77056 |
Product Code | ECX |
CFR Regulation Number | 868.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-14 |
Decision Date | 2014-03-14 |
Summary: | summary |