Guardian 51.14.000

Device Model:

51.14.000

Manufacturer:

OBL: Albert Waeschle (Guardian / Guardian Emergency and Resuscitation), Unit 11 Balena Close, Creekmoor Industrial Estate, Poole, Dorset BH17 7DB, UNITED KINGDOM.

OEM: Spirit Medical Co. Ltd., 2F - 68 Section 2, Guo Dao Road, Luzhon District, 24766 New Taipei City, TAIWAN ROC.

Measuring functions:

Blood pressure

Primary Client Use:

Intended for professional use

Measurement Site:

Upper Arm

Measurement Occurrence:

Single measurements only

Availability:

Available Currently

Availability according to Countries or Regions:

Ireland

Description:

The Guardian 51.14.000 is a mobile (floor, stand, trolly) manually-operated aneroid sphygmomanometer. Blood pressure measurements are taken from the upper arm. It is intended for professional use.

Assessment:

There appears to be no peer-reviewed clinical validation information available on the technology used in the Guardian 51.14.000 to measure blood pressure. However, this device appears to be very similar to another device by the same manufacturer or a device within a family of equivalent devices. At least one validation needs to be published and equivalence needs to be proven according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BP	Medaval	None	This is a manual device.

Device Family:

Guardian 51.10.000Z, Guardian 51.12.000Z, Guardian 51.14.000Z, Spirit CK-141Z, Spirit CK-142Z, Spirit CK-143Z
Legend: Z Almost Certain