The Fukuda Denshi SC-1800 (COL-SC-1800) 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.

While the technology used in the Fukuda Denshi SC-1800 (COL-SC-1800), 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 SC-1800 (COL-SC-1800) to measure peripheral oxygen saturation.

	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 (2021-2022)	Equivalence claim without published evidence