Custo Med custo screen 300
Device Name:
custo screen 300
Manufacturer:
custo med GmbH, Maria-Merian-Straße 6, D-85521 Ottobrunn, GERMANY.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for ambulatory blood pressure monitoring
Measurement Site:
Upper Arm
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Available Currently
Availability according to Countries or Regions:
Ireland
Device Manual:
Description:
The Custo Med custo screen 300 is an ambulatory blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the upper arm. It is intended for ambulatory blood pressure monitoring.
Assessment:
Medaval is in the process of checking the validation status of this device.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |