The following data is part of a premarket notification filed by Oxus, Inc with the FDA for Gce Zen-o Portable Oxygen Concentrator.
| Device ID | K162433 |
| 510k Number | K162433 |
| Device Name: | GCE Zen-O Portable Oxygen Concentrator |
| Classification | Generator, Oxygen, Portable |
| Applicant | OXUS, INC 2676 PALDAN Auburn Hills, MI 48326 |
| Contact | Ryan Lenarcic |
| Correspondent | Ryan Lenarcic OXUS, INC 2676 PALDAN Auburn Hills, MI 48326 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-31 |
| Decision Date | 2017-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08592346679832 | K162433 | 000 |
| 08592346658110 | K162433 | 000 |
| 08592346004337 | K162433 | 000 |
| 05060456420017 | K162433 | 000 |
| 05060456420000 | K162433 | 000 |
| 08592346904156 | K162433 | 000 |
| 08592346805477 | K162433 | 000 |