510(k) K221008 ยท MUH System, X-Ray, Extraoral Source, Digital
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
| Applicant | Shanghai Handy Medical Equipment Co., Ltd., Baoshan District, CN |
| Decision | Substantially Equivalent, Jun 22, 2022 |
| Received | Apr 5, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221008
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.