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 has not been clinically validated. Although equivalence to another device is claimed by the manufacturer, this has not been tested scientifically.
Hypertension CanadaGeneral useManufacturer declaration of equivalence