510(k) K001866 ยท LPP Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
TCM400
| Applicant | Radiometer Medical A/S, Bronshoj, DK |
| Decision | Substantially Equivalent, Dec 7, 2000 |
| Received | Jun 20, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001866
| 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 |
| Aug 31, 2006 | Radiometer America Inc D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor) Terminated |
KLK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.