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Accoson SIX00 Wall (AC0642A)
Device Name:
SIX00 Wall
Device Model:
AC0642A
Manufacturer:
Accoson Ltd., Grieg House, Block 1, Annickbank Campus, Annick Road, Irvine, Ayrshire KA11 4LF, UNITED KINGDOM.
Measuring functions:
Blood Pressure and PR
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Ireland
Description:
The Accoson SIX00 Wall (AC0642A) is a wall-mounted manually-operated aneroid sphygmomanometer. Blood pressure measurements are taken from the upper arm. 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 Wall (AC0642A) to measure blood pressure. However, this device appears to be very similar to another device by the same manufacturer or a device within a family of equivalent devices. At least one validation needs to be published and equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BP Medaval None This is a manual device.
Device Family:
Accoson SIX00 Desk (AC0632A)Z, Accoson SIX00 Stand (AC0662A)Z, Accoson SIX00 Wall (AC0642A)Z
Legend: Z Almost Certain