510(k) K043003 ยท LKD Monitor, Carbon-Dioxide, Cutaneous
TCM40 MONITORING SYSTEM
| Applicant | Radiometer Medical Aps, Bronshoj, DK |
| Decision | Substantially Equivalent, Mar 1, 2005 |
| Received | Nov 1, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K043003
| 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 |
| Aug 8, 2013 | Radiometer America Inc TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and Terminated |
LPP | None listed |
| Dec 1, 2011 | Radiometer America Inc TC pCO2 Electrodes, Model/Part #945-655-E5260, 510(k) #K043003.
Product Usage: The device is intended for used with the firm's TCM series monitor. The E260mpCO2 electrode is a non-invasive devi Terminated |
LKD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.