Omron RS2 (HEM-6121-E)

Device Name:RS2
Device Model:HEM-6121-E
Manufacturer:Sole: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600 8530, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Wrist
Measurement Occurrence:Single measurements only
Availability:Available Currently
Assessment:

While the technology used in the Omron RS2 (HEM-6121-E), to measure blood pressure, has been declared as being equivalent to that used in a validated device, 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.

It is recommended by the BIHS on the basis of a manufacturer declaration of equivalence. It is recommended by the DHL on the basis of a manufacturer declaration of equivalence.

Device Family:Omron RS1 (HEM-6120-D)D, Omron RS3 (HEM-6130-E)B,D (B BIHS Derivative, D DET Equivalence)