510(k) K081061 ยท FLL Continuous Measurement Thermometer
HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES
| Applicant | Harvard Medical Devices , Ltd., Tsimshatsui, Kowloon, HK |
| Decision | Substantially Equivalent, Jul 18, 2008 |
| Received | Apr 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081061
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.