TASK FORCE MONITOR 3040— 510(k) K014063

Clearance details

Applicant

Cnsystems Medizintechnik GmbH

Product code

Code DSB

Device class

Class 2

Regulation

21 CFR 870.2770

Advisory panel

Cardiovascular

Date received

2001-12-11

Decision date

2002-02-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Europe, AT

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• Z-0572-2016 — CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Impedance Cardiography (ICG), Electrocardiography (ECG), oscillometric Blood Pressure (oscBP) and continuous Blood Pressure (contBP). Furthermore Sympathic Tone and Parasympathic Tone are calculated by power spectral analysis of ECG (heart rate variability) and continuous blood pressure (blood pressure variability) as well as the Baroreceptor Reflex Sensitivity (BRRS). For use by medically trained personnel. It has been designed for diagnoses aiding and must not be used for vital sign monitoring of critically ill patients under absence of additional, suitable self-monitoring devices or medical trained personnel. The device measures continuously the subject's hemodynamic parameters without reporting any diagnosis. It is the physician's responsibility to make proper judgment based on these parameters.Class II·Terminated·Partners In Medicine Llc·20151201

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K014063.