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510(k) Data Aggregation

    K Number
    K123816
    Device Name
    DIGITAL ELECTROCARDIOGRAPHS
    Manufacturer
    SHENZHEN BIOCARE ELECTRONICS CO., LTD
    Date Cleared
    2013-02-27

    (77 days)

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

    SHENZHEN BIOCARE ELECTRONICS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Digital Electrocardiographs, iE 12A / iE 15S, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
    Device Description
    Digital Electrocardiographs, iE 12A / iE 15 / iE 15S, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device. All the models. iE 12A / iE 15 / iE 15S, of the proposed device. Digital Electrocardiographs, follow · the same design principle and similar technical specifications.
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    K Number
    K122712
    Device Name
    DIGITAL ELECTROCARDIOGRAPH
    Manufacturer
    SHENZHEN BIOCARE ELECTRONICS CO., LTD
    Date Cleared
    2012-10-25

    (51 days)

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

    SHENZHEN BIOCARE ELECTRONICS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Digital Electrocardiographs, ECG-8080/ iE 3S/ iE 12/ iE 12P, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
    Device Description
    Digital Electrocardiographs, ECG-8080/ IE 3S/ iE 12/ iE 12P, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paperthrough thermal printer. ECG data result and patient information could be stored in the memory of the device. All the models, ECG-8080/ iE 3S/ iE 12/ iE 12P, of the proposed device, Digital Electrocardiographs, follow the same design principle and similar technical specifications.
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    K Number
    K112431
    Device Name
    DIGITAL ELECTROCARDIOGRAPH
    Manufacturer
    SHENZHEN BIOCARE ELECTRONICS CO., LTD
    Date Cleared
    2011-09-22

    (30 days)

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

    SHENZHEN BIOCARE ELECTRONICS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Digital Electrocardiographs, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
    Device Description
    Digital Electrocardiographs, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device. All the models, ECG-3020 / ECG-3030 / ECG-3060 / ECG-6020 / ECG-1220 / ECG-1260 / ECG-1215 / ECG-1216, of the proposed device, Digital Electrocardiographs, follow the same design principle and similar technical specifications.
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    K Number
    K101876
    Device Name
    DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010
    Manufacturer
    SHENZHEN BIOCARE ELECTRONICS CO., LTD
    Date Cleared
    2011-03-01

    (238 days)

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

    SHENZHEN BIOCARE ELECTRONICS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.
    Device Description
    Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data and patient information could be stored in the memory of the device. All the models, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, of the proposed device, Digital Electrocardiographs, follow the same design principle and same technical specifications: They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.
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    K Number
    K100626
    Device Name
    DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
    Manufacturer
    SHENZHEN BIOCARE ELECTRONICS CO., LTD
    Date Cleared
    2010-05-21

    (77 days)

    Product Code
    KNG, REG
    Regulation Number
    884.2660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHENZHEN BIOCARE ELECTRONICS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FM-200 Doppler Fetal Heart Rate Detector is a hand-held, battery powered Doppler devices used for detecting fetal heart beats.
    Device Description
    Doppler fetal heart rate detector is a portable equipment to detect the heart rate of fetus in Obstetrics & Gynecology and delivery room. It can also be used at home or in public place for prenatal diagnosis on pregnant women. Doppler fetal heart rate detector is composed of the parts used for ultrasonic signal emitting and receiving, simulating signal processing, fetal heart rate calculation and display control.
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