510(k) K983887 ยท FLL Continuous Measurement Thermometer
UP-GRADE AND UP-GRADE PRO
| Applicant | Medisim, Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Feb 12, 1999 |
| Received | Nov 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983887
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2006 | Omron Healthcare, Inc. Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used to take an accurate patient temperature measurement in 4-6 seconds typically in the oral, Terminated |
FLL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.