510(k) K112189 ยท FLL Continuous Measurement Thermometer
THERMO PAL INFRARED EAR THERMOMETER
| Applicant | Digio2 International Co., Ltd., Flagstaff AZ, US |
| Decision | Substantially Equivalent, Jan 13, 2012 |
| Received | Jul 29, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112189
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.