Search Results
Found 1 results
510(k) Data Aggregation
K Number
K173505Device Name
FORA GTel Blood Glucose Monitoring System
Manufacturer
Date Cleared
2018-08-09
(269 days)
Product Code
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
ForaCare Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FORA GTel Blood Glucose Monitoring System consists of the FORA GTel Blood Glucose Test Strip and the FOR A GTel Blood Glucose meter.
The FORA GTel Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. It is intended for in vitro diagnostic use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. It is intended to be used by a single person and should not be shared.
Device Description
The FORA GTel Blood Glucose Monitoring System consists of FORA GTel blood glucose meter and FORA GTel blood glucose test strip which have been designed, tested, and proven to produce accurate blood glucose test result only when used in combination.
Ask a Question
Ask a specific question about this device
Page 1 of 1