The Fukuda Denshi DS-1200 is a patient monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology 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.

While the technology used in the Fukuda Denshi DS-1200, 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. There appears to be no peer-reviewed clinical validation information available on the technology used in the Fukuda Denshi DS-1200 to measure peripheral oxygen saturation.

	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 (2022)	Equivalence claim without published evidence