Omron Project Zero 2.0

Device Name:

Project Zero 2.0

Manufacturer:

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

Measuring functions:

Blood pressure

Primary Client Use:

Developed as a research version only - Never sold commercially

Measurement Site:

Wrist

Measurement Occurrence:

Continuous measurement

Availability:

Not made available

Description:

The Omron Project Zero 2.0 is an automatic blood pressure monitor. The accuracy of its blood pressure measurement technology has yet to be proven to MDR requirements. Blood pressure measurements are taken from the wrist. It is intended for use only as a reasearch version.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Omron Project Zero 2.0 to measure blood pressure.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	Not applicable	This is a research device only and not available for purchase.