Fukuda Denshi FBX-1000
Device Model:
FBX-1000
Manufacturer:
Fukuda Denshi Co. Ltd., 2-23-5 Kita Ueno, Taito-Ku, Tokyo 110-0014, JAPAN.
Measuring functions:
Blood Pressure, SpO2 and PR
Primary Client Use:
Intended for patient monitoring
Measurement Site:
BP: Upper Arm; SpO2: Finger
Measurement Occurrence:
BP: Single measurements only; SpO2: Continuous measurement
Availability:
Available Currently
Availability according to Countries or Regions:
Japan
Description:
The Fukuda Denshi FBX-1000 is a patient monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements and information regarding the accuracy of its oxygen saturation measurement technology does not appear to be available. Blood pressure measurements are taken from the upper arm and oxygen saturation measurements are taken from the finger. It is intended for bedside patient monitoring.
Assessment:
While the technology used in the Fukuda Denshi FBX-1000, to measure blood pressure, has been assessed, the results of the study have not been published and cannot be verified. There appears to be no peer-reviewed clinical validation information available on the technology used in the Fukuda Denshi FBX-1000 to measure peripheral oxygen saturation.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | None | While a clinical validation is claimed, it cannot be checked properly. |
| BP | Japanese Society of Hypertension | Professional use (2023-2024) | Unpublished validation |