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K Number
K171822Device Name
NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)
Manufacturer
Biotest Medical Corporation
Date Cleared
2017-09-20
(93 days)
Product Code
NBW, OVE
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
Biotest Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) consists of the NuvoMed Wireless Blood Glucose Monitor and the NuvoMed Blood Glucose Test Strip. The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is intended to be used by a single person and should not be shared.
The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program.
The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
Device Description
The NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) is a product kit consisting of a blood glucose meter, test strips, a lancing device, sterile lancets, instructions for use, and a carrying case. No control solution is included in the kit; however, user may purchase NuvoMed Control Solution Level 1, 2 or 3 from his/her system provider if needed. The NuvoMed Blood Glucose Meter uses NuvoMed Blood Glucose Test Strips. Neither the meter nor the test strips will work when used with any other brand of glucose products.
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K Number
K171785Device Name
WowGoHealth Blood Glucose Monitoring System
Manufacturer
Biotest Medical Corporation
Date Cleared
2017-09-15
(92 days)
Product Code
NBW, OVE
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
Biotest Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) consists of the WowGoHealth Blood Glucose Monitor and the WowGoHealth Blood Glucose Test Strip. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used by a single person and should not be shared.
The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program.
The Wow GoHealth Blood Glucose Monitoring System (Model GSH-BGM902) should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly).
Device Description
The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is a product kit consisting of a blood glucose meter (meter), test strips, a lancing device, lancets, and instructions for use. Control solution Level 1, Level 2 or 3 are available and sold separately. When glucose reacts with the reagents on the test strips, an electrical current is produced. The current is proportional to the glucose concentration in the blood sample. The meter will calculate glucose concentration based on the current measured. The device can show results either in "mg/dL" or "mmol/L". The factory set default for the meter is mg/dL. Apart from the existing measurement features and user interface of the device's predicate, the device is featured with Bluetooth mediated data transmission functionality which wirelessly transfers the latest test result to an APP run on a mobile device every time when a test is performed successfully.
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