The following data is part of a premarket notification filed by Ox-gen Inc. with the FDA for Ox-gen Flexible O2 Generation System, Model 6-ox-03.
| Device ID | K033863 |
| 510k Number | K033863 |
| Device Name: | OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03 |
| Classification | Generator, Oxygen, Portable |
| Applicant | OX-GEN INC. PO BOX 5867 Boise, ID 83702 |
| Contact | Frank Fosella |
| Correspondent | Frank Fosella OX-GEN INC. PO BOX 5867 Boise, ID 83702 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-12 |
| Decision Date | 2005-08-22 |
| Summary: | summary |