Merlin Medical W4329 M-Pulse IMPACT
Device Name:
M-Pulse IMPACT
Device Model:
W4329
Manufacturer:
OBL: Williams Medical Supplies Ltd. (Merlin Medical), Craiglas House, The Maerdy Industrial Estate, Rhymney, Tredegar, Gwent NP22 5PY, UNITED KINGDOM.
OEM: Edan Instruments Inc., No. 15 Jinhui Rd., Jinsha Community, Kengzi Subdistrict, Pingshan District, 518122 Shenzhen, CHINA.
Measuring functions:
SpO2, Pulse Rate
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 W4329 M-Pulse IMPACT 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 W4329 M-Pulse IMPACT, 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: