510(k) K214094 ยท FXX Mask, Surgical
ROKI Surgical Mask
| Applicant | Roki Co., Ltd., Hamamatsu-Shi, JP |
| Decision | Substantially Equivalent, Feb 24, 2022 |
| Received | Dec 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K214094
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.