The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Linde Oxygen Walker Sys. Mark Ii-l.
Device ID | K791902 |
510k Number | K791902 |
Device Name: | LINDE OXYGEN WALKER SYS. MARK II-L |
Classification | Unit, Liquid-oxygen, Portable |
Applicant | UNION CARBIDE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BYJ |
CFR Regulation Number | 868.5655 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-09-25 |
Decision Date | 1979-10-17 |