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Intuity POGO Automatic (GMM0002)
Device Name:
POGO Automatic
Device Model:
GMM0002, 00856176008001
Manufacturer:
Intuity Medical Inc. , 526 Almanor Avenue, Sunnyvale, CA 94085, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Intuity POGO Automatic (GMM0002) 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 taken from the finger. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Intuity POGO Automatic (GMM0002), 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