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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
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 manually-operated mobile (floor, stand, trolly) aneroid sphygmomanometer. Measurements are taken from the upper arm and it is intended for professional use. This device has been discontinued by the manufacturer but may be available through certain outlets.

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. At least one validation needs to be published and equivalence needs to be proven according to protocols compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneThis 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 (Z Almost Certain)