Kawe Mastermed C - Wall (32750)
Device Name:
Mastermed C (Wall)
Device Model:
04.32750.n32 (n: 0 blue, 2 black, 6 grey)
Manufacturer:
Kirchner & Wilhelm GmbH + Co. KG (KaWe), Eberhardstraße 56, 71679 Asperg, GERMANY.
Measuring functions:
Blood Pressure
Primary Client Use:
Intended for professional use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Device Manual:
Description:
The Kawe Mastermed C - Wall (32750) 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 Kawe Mastermed C - Wall (32750) 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:
Kawe Mastermed C - Tabletop (32730)Z, Kawe Mastermed C - Stand (32740)Z, Kawe Mastermed C - Wall (32750)Z
Legend: Z Almost Certain