The following data is part of a premarket notification filed by Praxair Distribution, Incorporated. with the FDA for Medipure Oxygen-lc System.
Device ID | K153518 |
510k Number | K153518 |
Device Name: | Medipure Oxygen-LC System |
Classification | Cylinder, Compressed Gas, And Valve |
Applicant | PRAXAIR DISTRIBUTION, INCORPORATED. 175 EAST PARK DRIVE Tonawanda, NY 14150 |
Contact | Michael Skrjanc |
Correspondent | Audrey Swearingen EMERGO GLOBAL CONSULTING, LLC 816 CONGRESS AVENUE SUITE 1400 Austin, TX 78701 |
Product Code | ECX |
CFR Regulation Number | 868.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-12-08 |
Decision Date | 2016-06-03 |
Summary: | summary |