TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM— 510(k) K093154

Clearance details

Applicant

Radiometer Medical Aps

Product code

Code LKD

Device class

Class 2

Regulation

21 CFR 868.2480

Advisory panel

Anesthesiology

Date received

2009-10-06

Decision date

2010-02-05

Decision

Substantially Equivalent

Clearance type

Traditional

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-1595-2016 — TCM CombiM Modules 903-111Class II·Terminated·Radiometer America Inc·20151118
• Z-2417-2015 — 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 used with the TCM CombiM monitoring system and the Philips TcG10 module. The TCM CombiM monitoring system is intended for continuous transcutaneous monitoring of carbon dioxide (tcpCO2) and oxygen (tcpO2) partial pressures.Class II·Terminated·Radiometer America Inc·20150716

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093154.