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510(k) Data Aggregation

    K Number
    K191106
    Device Name
    C50 and C80 Multi-parameter Patient Monitor
    Manufacturer
    Shenzhen Comen Medical Instruments Co.,Ltd.
    Date Cleared
    2019-12-13

    (232 days)

    Product Code
    MHX, CBQ, CBR, CBS, CCK, CCL, DPS, DQA, DRT, DSB, DSI, DSJ, DSK, DXG, DXN, FLL, GXY, MLD, NHO, NHP, NHQ, OLW
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Comen Medical Instruments Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index). All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: · The ICG monitoring is applicable to the adult patients of 122~229cm in height and 30~159Kg (67~341 pounds) in weight only; · NIBP measurement continual mode is not applicable to neonates; · Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients; The monitors are to be used in general healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. The monitors are not intended for home use.
    Device Description
    The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index). All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The ICG monitoring is applicable to the adult patients of 122~229cm in height and 30~159Kg (67~341 pounds) in weight only; • NIBP measurement continual mode is not applicable to neonates; • Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients; Those monitors provide patient monitoring capabilities by using corresponding accessories. The multi-parameter Patient monitor, model: C50 and C80 have same design principle and technical characteristics: But the software in the host and modules and components are different. The differences between C50 and C80 are ICG, BIS and size of monitor.
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    K Number
    K173454
    Device Name
    Multi-parameter Patient Monitor, models C30
    Manufacturer
    Shenzhen Comen Medical Instruments Co.,Ltd.
    Date Cleared
    2018-08-16

    (283 days)

    Product Code
    MHX, DOA, DPS, DRT, DSB, DSJ, DSK, DXN, FLL
    Regulation Number
    870.1025
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Comen Medical Instruments Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. It's used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. All parameters can be applied to adult, pediatric or neonate. The Patient Monitor is not intended to be used on the patients with pacemaker. The monitor is used for monitoring the clinical patients, so only the doctors and nurses who are qualified through training can use these monitors.
    Device Description
    C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is intended to be used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. Other parameters can be applied to adult, pediatric or neonate.
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