TCM40 MONITORING SYSTEM— 510(k) K043003

Clearance details

Applicant

Radiometer Medical Aps

Product code

Code LKD

Device class

Class 2

Regulation

21 CFR 868.2480

Advisory panel

Anesthesiology

Date received

2004-11-01

Decision date

2005-03-01

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Bronshoj, DK

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• Z-1755-2020 — 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 Usage: It is indicated for use on pediatrics and adults.Class II·Terminated·Radiometer Medical ApS·20200220
• Z-1930-2013 — TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.Class II·Terminated·Radiometer America Inc·20121127

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043003.