510(k) K162433 ยท CAW Generator, Oxygen, Portable
GCE Zen-O Portable Oxygen Concentrator
| Applicant | Oxus, Inc., Auburn Hills MI, US |
| Decision | Substantially Equivalent, May 24, 2017 |
| Received | Aug 31, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162433
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2025 | Ohio Medical Corporation GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S Open, Classified |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.