510(k) K230969 ยท CAW Generator, Oxygen, Portable
Oxygen Concentrator
| Applicant | Jiangsu Jumao X-Care Medical Equipment Co., Ltd., Danyang, CN |
| Decision | Substantially Equivalent, Nov 9, 2023 |
| Received | Apr 5, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230969
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2025 | JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L Open, Classified |
CAW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.