510(k) K201384 ยท DQA Oximeter
Pulse Oximeter
| Applicant | Shenzhen Raysintone Technology Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 7, 2020 |
| Received | May 26, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201384
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.