ABN Clock (Mobile) (AS-081M)

Device Name:

Clock (Mobile)

Device Model:

AS-081M

Manufacturer:

ABN Medical, Ji Tembokan RT 01/01, DS Cipeundear Padalarang, 40553, INDONESIA.

Measuring functions:

Blood Pressure and PR

Primary Client Use:

Intended for professional use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Discontinued but still available

Description:

The ABN Clock (Mobile) (AS-081M) is a mobile (floor, stand, trolly) 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 ABN Clock (Mobile) (AS-081M) 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 Assessment	Recommendation	Basis
BP	Medaval	None	This is a manual device.

Device Family:

ABN Clock (Desktop) (AS-081D)Z, ABN Clock (Mobile) (AS-081M)Z, ABN Clock (Wall) (AS-081W)Z, ABN Regal (AS-081R)Z
Legend: Z Almost Certain