Medisana BU 584 Connect (51584)
Device Name:
BU 584 Connect
Device Model:
51584
Manufacturer:
OBL: Medisana AG, Jagenbergstraße 19, D-41468 Neuss, GERMANY.
OEM: Health & Life Co. Ltd., 9F - 186 Jian 1st Rd., Zhonghe Dist., New Taipei City 23553, TAIWAN ROC.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Upper Arm
Measurement Occurrence:
Single measurements only
Connected Health Technologies:
Bluetooth
Availability:
Available Currently
Device Manual:
Description:
The Medisana BU 584 Connect (51584) 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. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Medisana BU 584 Connect (51584), to measure blood pressure, has been declared, on the manufacturer website, as being equivalent to that used in a clinically validated device, no evidence has been published to show that the devices have been compared according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Not recommended | This device has not been shown to have been clinically validated. |
Device Family:
H&L HL858CBY, Medisana BU 580 Connect (51580)Y, Medisana BU 584 Connect (51584)Y
Legend: Y Internal declaration
Legend: Y Internal declaration