Kawe Mastermed T5 - Tabletop/Wall (12730)
Device Name:
Mastermed T5 (Tabletop/Wall)
Device Model:
04.12730.n32 (n: 0 blue, 2 black)
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:
Discontinued but still available
Description:
The Kawe Mastermed T5 - Tabletop/Wall (12730) is a desk (tabletop) or wall-mounted manually-operated aneroid sphygmomanometer. Blood pressure measurements are taken from the upper arm. It is intended for professional 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 Kawe Mastermed T5 - Tabletop/Wall (12730) 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 T5 - Tabletop/Wall (12730)Z, Kawe Mastermed T5 - Stand (12740)Z
Legend: Z Almost Certain