Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K101024
    Device Name
    KENZ CARDY302 MAX
    Manufacturer
    SUZUKEN CO., LTD.
    Date Cleared
    2011-01-06

    (268 days)

    Product Code
    MWJ
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUZUKEN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cardy302Max Compact Digital Holter Recorder System is intended to acquire ambulatory 2 or 3 channel ECG signals from the chest surface of pediatric or adult patients. The device stored this data along with patient demographic information onto a removable SD memory card. The Cardy302Max Compact Digital Holter Recorder System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner in a hospital or medical professional's facility. The Cardy302Max Compact Digital Holter Recorder System does not perform any analysis of the ECG data. The Cardy302Max Compact Digital Holter Recorder System is not intended for use on patients weighing less than 10 kg.
    Device Description
    The Cardy302Max Compact Digital Holter System is designed to acquire ambulatory 2 or 3 channels of ECG signal from the chest surface of pediatric or adult patients for up to 48 hours. The device stores the acquired ECG data on its removable memory card. The Cardy Controller02 downloads patient demographic information into the Cardy302Max Compact Digital Holter Recorder and allows the user to check the signal quality of the ECG data at hookup time. At the end of recording, the ECG data can be transferred to the controller by removing the SD memory card from the recorder and installing it into the Cardy Controller02.
    Ask a Question
    K Number
    K092389
    Device Name
    DISPOSAL ECG ELECTRODES, MODEL EASYRODE
    Manufacturer
    SUZUKEN CO., LTD.
    Date Cleared
    2009-10-13

    (69 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUZUKEN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Easyrode is intended for use in ECG Monitoring. The Easyrode can be used in all ECG applications where standard ECG monitoring electrodes are used. This electrode can be used for short term and long term (2 Days) monitoring.
    Device Description
    Easyrode is a self-adhesive, non-sterile, single use disposable electorode which includes a silver/silver chloride sensing element and conductive gel. These electrodes include a pressure sentive adhesive non-woven tape which hold the conductive elements of the electrodes in place on the patient's skin for short or long term ECG procedures.
    Ask a Question
    K Number
    K001896
    Device Name
    KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC
    Manufacturer
    SUZUKEN CO., LTD.
    Date Cleared
    2001-01-08

    (201 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    SUZUKEN CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1