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BIOS BD250 (Precision 12.0 – Protocol 7D MII)

Device Name:Precision 12.0 - Protocol 7D MII
Device Model:BD250
Manufacturer:OBL: BIOS Medical, 16975 Leslie Street, Newmarket, Ontario L3Y 9A1, CANADA.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Discontinued but still available
Assessment:

While the technology used in the BIOS BD250 (Precision 12.0 - Protocol 7D MII), 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 CanadaSelf-measurement (Silver)Manufacturer declaration of equivalence