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510(k) Data Aggregation
K Number
K122181Device Name
EBCHEK BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
Date Cleared
2013-08-15
(388 days)
Regulation Number
862.1345Why 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
K091765Device Name
EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
Date Cleared
2010-01-19
(216 days)
Regulation Number
862.1345Why 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
K062555Device Name
EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G
Manufacturer
Date Cleared
2006-12-27
(119 days)
Regulation Number
862.1345Why 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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