The Fukuda Denshi BDS-1001 is a patient 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 bedside patient monitoring.

While the technology used in the Fukuda Denshi BDS-1001, to measure blood pressure, has been declared as being equivalent to that used in another device, not only has 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, but there is no evidence provided on a validation of the other device.

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Not recommended	This device has not been shown to have been clinically validated.
BP	Japanese Society of Hypertension	Professional use (2023-2024)	Implied equivalence to the Fukuda Denshi NIBP-771 claim without published evidence