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Philosys Gmate Voice (PG-301)
Device Name:
Gmate Voice
Device Model:
PG-301
Manufacturer:
Philosys Inc., Suite 218, 304 Park Avenue, NY 10010, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for both professional use and self-measurement
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Device Accessibility:
Voiced instructions and results
Availability:
Available Currently
Device Manual:
Description:
The Philosys Gmate Voice (PG-301) is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.
Assessment:
While the technology used in the Philosys Gmate Voice (PG-301), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None While a clinical validation is claimed, it cannot be checked properly.
BG Institute of Health Economics (CA) General use No evidence provided