Medisana PM-100 (79455)

Device Name:

PM-100

Device Model:

79455

Manufacturer:

OBL: Medisana AG, Jagenbergstraße 19, D-41468 Neuss, GERMANY.

OEM: Beijing Choice Electronic Technology Co. Ltd. (ChoiceMMed), 4F Jingyang Science and Technology Building, 15 Xijing Road, Shijingshan District, Beijing 100041, 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 Medisana PM-100 (79455) 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 Medisana PM-100 (79455), 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:

ChoiceMMed MD300C2Y, Merlin Medical W4350Y, Medisana PM-100 (79454)Y, Medisana PM-100 (79455)Y
Legend: Y Internal declaration