510(k) K210878 ยท FXX Mask, Surgical
Surgical Face Mask (Model: CM2006, CM2008, A88)
| Applicant | Shenzhen Realtone Medical Appliance Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Sep 28, 2021 |
| Received | Mar 24, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210878
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.