510(k) K162509 ยท FLL Continuous Measurement Thermometer
Infrared Non-contact Thermometer, Model ACT8100
| Applicant | Easywell Biomedicals, Inc., Hsinchu, TW |
| Decision | Substantially Equivalent, Mar 10, 2017 |
| Received | Sep 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162509
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.