510(k) K172234 ยท CAW Generator, Oxygen, Portable
Oxygen Concentrator
| Applicant | Sysmed (China) Co., Ltd., Shenyang, CN |
| Decision | Substantially Equivalent, Jun 1, 2018 |
| Received | Jul 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172234
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.