510(k) K093154 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
| Applicant | Radiometer Medical Aps, Bronshoj, DK |
| Decision | Substantially Equivalent, Feb 5, 2010 |
| Received | Oct 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093154
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2020 | Radiometer Medical ApS TCM4 Base unit, Ref 391-880, UDI:(01)05700693918808, used with the monitor modules TCM4 (902-778), TCM40 (902-778, 902-946 or 902-862), TCM400 (902-564), TOSCA (903-044) and CombiM (903-111) - Product Terminated |
LKD | None listed |
| Nov 18, 2015 | Radiometer America Inc TCM CombiM
Modules 903-111 Terminated |
LKD | None listed |
| Aug 19, 2015 | Radiometer America Inc Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873. The Fixation Kit N20 is used to apply tc Sensor 84 and tc Sensor 54 on the skin of a patient. TC sensor 84 and 54 are Terminated |
LKD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.