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Accoson SIX00 Stand (AC0662A)

Device Name:SIX00 Stand
Device Model:AC0662A
Manufacturer:Accoson Ltd., Grieg House, Block 1, Annickbank Campus, Annick Road, Irvine, Ayrshire KA11 4LF, UNITED KINGDOM.
Measuring functions:Blood pressure
Primary Client Use:Intended for professional use
Measurement Site:Upper Arm
Measurement Occurrence:Single measurements only
Availability:Available Currently
Description: The Accoson SIX00 Stand (AC0662A) is a manually-operated mobile (floor, stand, trolly) aneroid sphygmomanometer. Measurements are taken from the upper arm and it is intended for professional use.
Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Accoson SIX00 Stand (AC0662A) to measure blood pressure. However, this device appears to be very similar to another device by the same manufacturer. At least one validation needs to be published and equivalence needs to be proven according to protocols compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneThis is a manual device.

Device Family:Accoson SIX00 Desk (AC0632A)Z, Accoson SIX00 Stand (AC0662A)Z, Accoson SIX00 Wall (AC0642A)Z (Z Almost Certain)