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 |