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Colin HBP-2070

Device Model:HBP-2070
Manufacturer:Colin Medical Instruments Corp., 5850 Farinon Dr, San Antonio, TX 78249, UNITED STATES.
Measuring functions:Blood pressure, SpO2, Temperature, ECG, Respiration
Primary Client Use:Intended for patient monitoring
Measurement Site:Upper Arm
Measurement Occurrence:Single, intermittent and continuous measurements
Availability:Available Currently
Assessment:

While the technology used in the Colin HBP-2070, to measure blood pressure, has been claimed as being equivalent to that used in another device, not only has no evidence has been published to show that the devices were 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 AssessmentRecommendationBasis
MedavalNot recommendedThis device has not shown to have been clinically validated.
Japanese Society of HypertensionProfessional use (2016-2018)Implied equivalence to the Omron M3500 NIBP Module

Device Family:Colin BP-608EVJ, Colin BP-A308J, Colin BP-A308DJ, Colin HBP-2070J, Colin HBP-2071J (J JHS Implied Equivalence)