The following data is part of a premarket notification filed by Union Carbide Corp. with the FDA for Mark Iii Oxygen Walker Sys-low Press.
| Device ID | K830337 |
| 510k Number | K830337 |
| Device Name: | MARK III OXYGEN WALKER SYS-LOW PRESS |
| 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 | 1983-02-01 |
| Decision Date | 1983-03-17 |