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Pharma-Smart PS-2000C

Device Model:PS-2000C
Manufacturer:Pharma-Smart, Suite 1 Building A, 3495 Winton Place, Rochester, NY 14623, UNITED STATES.
Measuring functions:Blood pressure
Primary Client Use:Intended for use as a public facility
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

While the technology used in the Pharma-Smart PS-2000C, to measure blood pressure, has been declared as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device failed clinical validation.
Hypertension CanadaPublic use (Gold)Manufacturer declaration of equivalence