Guardian 55.09.113 Clip-On
Device Name:
Clip-On
Device Model:
55.09.113
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
Description:
The Guardian 55.09.113 Clip-On is a hand-held 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 55.09.113 Clip-On 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: