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510(k) Data Aggregation

    K Number
    K122181
    Device Name
    EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    Date Cleared
    2013-08-15

    (388 days)

    Product Code
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISGENEER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The eBchek Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The eBchek Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The eBchek Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The eBchek Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes mellitus or for neonatal use. The eBchek Glucose Meter contains some speaking functions, but is not intended for use by the visually impaired. eBchek Blood Glucose Test Strips are for use with the eBchek Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. eB-series Control Solutions are for use with the eBchek Blood Glucose Meter and eBchek Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
    Device Description
    Based on an electrochemical biosensor technology and the principle of capillary action, eBchek Blood Glucose Monitoring System only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and the blood glucose result is displayed on the meter. This system contains some speaking functions, but is not intended for use by the visually impaired. The eBchek Blood Glucose Monitoring System consists of the eBchek Meter, eBchek test strips with instruction, lancing device, lancets, code card, two AAA Batteries, users manual, carrying case. eB-series control solutions (previously cleared in K062555 as eBsensor control solution) with two different glucose concentration ranges (Level 1 and Level 2) are available but sold separately.
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    K Number
    K091765
    Device Name
    EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    Date Cleared
    2010-01-19

    (216 days)

    Product Code
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISGENEER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The eBcarryon Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The eBcarryon Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not for use on neonates. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
    Device Description
    Based on an electrochemical biosensor technology and the principle of capillary action, eBcarryon Blood Glucose Monitoring System only needs a small amount of blood . Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 10 seconds.
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    K Number
    K062555
    Device Name
    EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G
    Manufacturer
    Date Cleared
    2006-12-27

    (119 days)

    Product Code
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    VISGENEER, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The eBsensor Blood Glucose Monitoring System, eB-G is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. Testing is done outside the body ( in vitro diagnostic use). It is indicated for use at home ( over the counter [OTC] ) by person with diabetes, or in clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.
    Device Description
    Based on an electrochemical biosensor technology and the principle of capillary action, eBsensor Blood Glucose Monitoring System, eB-G only needs a small amount of blood. Capillary action at the end of the test strip draws the blood into the action chamber and your blood glucose result is precisely and displayed in 10 seconds.
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