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BIOS BD350 aka 3MS1-4K (Precision 10.0 – Ultra) (V2)

Device Name:Precision 10.0 - Ultra
Device Model:BD350 and 3MS1-4K
Manufacturer:

OBL: BIOS Medical, 16975 Leslie Street, Newmarket, Ontario L3Y 9A1, CANADA.

OEM: Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN PRC.

Measuring functions:Blood pressure, Atrial fibrillation
Primary Client Use:Intended for self-measurement and home use with atrial fibrillation detection
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The BIOS BD350 aka 3MS1-4K (Precision 10.0 - Ultra) (V2) is a non-clinically-validated automatic blood pressure monitor. Measurements are taken from the upper arm and, with atrial fibrillation detection, it is intended for self-measurement and home use.
Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the BIOS BD350 aka 3MS1-4K (Precision 10.0 - Ultra) (V2) to measure blood pressure.

Accuracy AssessmentRecommendationBasis
MedavalNot recommendedThis device has not been clinically validated.
Hypertension CanadaSelf-measurement (Gold)Manufacturer declaration of equivalence