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510(k) Data Aggregation

    K Number
    K090486
    Device Name
    ASTHMA MONITOR MODEL, AM1
    Manufacturer
    CARDINAL HEALTH GERMANY 234 GMBH
    Date Cleared
    2009-05-06

    (70 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDINAL HEALTH GERMANY 234 GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Asthma Monitor AM1+ / AM1+ BT from Cardinal Health is an electronic measurement device to monitor the lung function (determination of the respiratory flows and volume) with high reproducibility wherever and whenever is a need of. The AM1+ / AM1+ BT measures the flow during expiration serving for the calculation of further parameters as FEV1. The AM1+ / AM1+ BT is used to monitor the respiratory status of human beings in the areas asthma, chronic obstructive pulmonary disorder and in areas like occupational medicine, clinical trials and disease management. The patient is informed of the results by numeric values for selected parameters (e.g. PEF, FEV1). Furthermore a visual control unit, displayed as a kind of traffic lights, allows an immediate indication of the measurement based on criteria defined by the patient's physician. The device saves the results of a measurement (always with date and time) automatically in an internal database. The memory capacity is designed to store up to 400 measurements. In addition, a questionnaire functionality can be called up by the use of a software package (AMOS) to record e.g. the "Quality of Life" status. When enabled, the AM1+ / AM1+ BT can be programmed with a couple of questions, where the patient can select then from a couple of different answers. This information is also stored in the internal database and can be transmitted for evaluation to a standard PC using the software package AMOS. The AM1+ / AM1+ BT is designed to replace ordinary peak flow meter, diary and pencil by a single system. Easy handling, sturdy and handy design allow the Asthma Monitor AM1+ / AM1+ BT being used almost everywhere: at work, at home, in school, for experts opinion, research or clinical trial purposes and in occupational medicine. The AM1+ operates with serial data transmission whereas the AM1+ BT can be operated with serial and Bluetooth data transmission.
    Device Description
    The Asthma Monitor AM1+ / AM1+ BT is a medical device (peak flow meter with symptom diary) providing following characteristics: - Handheld device . - Battery operation . - Storing capacity of 400 measurements / 2000 entries . - Measurement Parameters: PEF and FEV1 . - Accuracy Flow: ± 5% or ± 20 l/min . - Accuracy Volume: ± 3% or ± 0.05 liter . - Data transmission to computer via Bluetooth and Serial (AM1+ BT) . - Data transmission to computer via Serial (AM1+) . - Flow sensor (single patient use) . - Mouthpiece (single patient use) .
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    K Number
    K082539
    Device Name
    MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
    Manufacturer
    CARDINAL HEALTH GERMANY 234 GMBH
    Date Cleared
    2008-12-02

    (91 days)

    Product Code
    BTY, DPS
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDINAL HEALTH GERMANY 234 GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MasterScope / MasterScope ECG is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow volume measurements. Mostly it will be used for COPD and Asthma patients. In addition it is intended for measuring a 3/6- or 12-channel surface electrocardiogram (ECG) of a patient. The acquired ECG can be recorded and displayed on the screen or printed on paper. 12-channel ECG's are analysed automatically and suggestions for the interpretation of the 12-channel ECG can be made by the software. MasterScope / MasterScope ECG can be used for non interpretive applications for patients with an age of 4 years and older and a weight of 20 kg or higher. MasterScope / MasterScope ECG is intended for use in routine ECG recording by trained physicians in the office or hospital. MasterScope / MasterScope ECG is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients. MasterScope CT (Clinical Trial version) incorporates the identical measurements. In addition it offers workflow control elements to restrict the use of the equipment (e.g. individual access rights are defined for different user roles like investigator, doctor, study nurse, trainer and service personnel). The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm. A qualified physician has to reassess all MasterScope / MasterScope ECG measurements. An interpretation by MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope / MasterScope ECG represent partial qualitative and quantitative information on the patient's cardiovascular condition and no therapy or drugs can be administered based solely on the interpretation statements. The MasterScope / MasterScope ECG / MasterScope CT is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.
    Device Description
    MasterScope / MasterScope ECG is an active device providing following characteristics: Mains operation Personal Computer System Graphic user interface Windows XP Professional LAB Software Powerful database for storing patient- and test data Ultrasonic handle Pneumotach handle/shutter ECG Amplifier pulmonary functions a) - Measurement with ultrasonic handle or pneumotach handle . - Slow spirometry (VCin, VCex, VCmax, ERV, IC, VT, IRV, MV, BF, TI, TE, ... ) . - Forced spirometry (FVCin, FVC, FEV1, PEF, FEV1/FVC, FEF 50, FEF 75, PIF, ... ) . - Flow-Volume and Volume- Time Loop, pre/post tests - MV measurement - R Occlusion (only with pneumotach handle) - Trending capabilities . - Patient Incentive animations - Interpretation modules . b) ECG functions - Simultaneous acquisition of the 12 standard leads . - Storage of 10 seconds of acquired ECG signal - Digital filters for base-line drift and mains interference suppression . - Interpretation program Hanover ECG System (HES) providing the following additional information: - Representatives templates of each lead including markers on fiducially points . - Summary of mean measurements - Rhythm Analysis statements . - Signal noise detection and information - Specific findings on QRS complex . - Conduction statements . - QRS T diagnostic statements . - Arrhythmia monitoring detection . - Heart Rate Variability
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