The following data is part of a premarket notification filed by Linde Gas North America Llc with the FDA for Liv Linde Intergrated Valve-portable Oxygen System, Model M706.
Device ID | K101792 |
510k Number | K101792 |
Device Name: | LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 |
Classification | Cylinder, Compressed Gas, And Valve |
Applicant | LINDE GAS NORTH AMERICA LLC 575 MOUNTAIN AVE Murray Hill, NJ 07974 |
Contact | Michael Piacenza |
Correspondent | Michael Piacenza LINDE GAS NORTH AMERICA LLC 575 MOUNTAIN AVE Murray Hill, NJ 07974 |
Product Code | ECX |
CFR Regulation Number | 868.2700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-06-28 |
Decision Date | 2011-03-18 |
Summary: | summary |