510(k) K213079 ยท FLL Continuous Measurement Thermometer
Ear Thermometer, Model ET001
| Applicant | Guangzhou Berrcom Medical Device Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Feb 18, 2022 |
| Received | Sep 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213079
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.