510(k) K223518 ยท PNN Orthodontic Software
iOrtho
| Applicant | Shanghai EA Medical Instruments Co., Ltd., Wuxi, CN |
| Decision | Substantially Equivalent, Jun 13, 2023 |
| Received | Nov 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223518
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.