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BIOS BD350 aka 3MS1-4K (Precision 10.0 - Ultra) (V3)
Device Name:
Precision 10.0 - Ultra
Device Model:
BD350 and 3MS1-4K
Manufacturer:

Distributer: Thermor Ltd., 16975 Leslie Street, Newmarket, Ontario L3Y 9A1, CANADA.

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

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

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:
Discontinued but still available
Availability according to Countries or Regions:
Canada
Device Manual:
Description:
The BIOS BD350 aka 3MS1-4K (Precision 10.0 - Ultra) (V3) is an automatic blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. With atrial fibrillation detection, it is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
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) (V3) to measure blood pressure.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval Not recommended This device has not been clinically validated.
BP Hypertension Canada Self-measurement (Gold) Manufacturer declaration of equivalence