510(k) K212945 ยท FLL Continuous Measurement Thermometer
Sterile Disposable Temperature Probe
| Applicant | Shenzhen Envisen Industry Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Mar 1, 2022 |
| Received | Sep 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212945
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.