510(k) K191283 ยท FLL Continuous Measurement Thermometer
Infrared Thermometer, Breeze model
| Applicant | Suzhou Melodicare Medical Technology Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Oct 18, 2019 |
| Received | May 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191283
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.