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Colin BP-608EV

Colin BP-608EV
Device Model:BP-608EV
Manufacturer:

OBL: Colin Medical Instruments Corp., 5850 Farinon Dr, San Antonio, TX 78249, UNITED STATES.

OEM: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.

Measuring functions:Blood pressure, Vital Signs
Primary Client Use:Intended for patient monitoring
Measurement Site:Finger
Measurement Occurrence:Continuous measurement
Availability:Available Currently
Assessment:

While the technology used in the Colin BP-608EV, 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)