510(k) K011059 ยท FLL Continuous Measurement Thermometer
INFARED EAR THERMOMETER, MODEL TH8 SERIES
| Applicant | Radiant Innovation, Inc., Great Neck NY, US |
| Decision | Substantially Equivalent, Sep 17, 2001 |
| Received | Apr 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011059
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.