Merlin-Medical OXY-300
Device Model:
OXY-300
Manufacturer:
OBL: Williams Medical Supplies Ltd. (Merlin Medical), Craiglas House, The Maerdy Industrial Estate, Rhymney, Tredegar, Gwent NP22 5PY, UNITED KINGDOM.
OEM: Microlife Corporation, 9F - 431 RuiGuang Road, NeiHu, Taipei 11492, TAIWAN ROC.
Measuring functions:
SpO2 and PR
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Merlin-Medical OXY-300 is a fingertip automatic pulse oximeter. Information regarding the accuracy of its oxygen saturation measurement technology does not appear to be available. Oxygen saturation measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
While the technology used in the Merlin-Medical OXY-300, to measure peripheral oxygen saturation, has been declared, on the manufacturer website, as being equivalent to that used in a clinically 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.
Device Family: