DEVICE DETAILS
| NAME OF DEVICE | FINGER PULSE OXIMETER |
|---|---|
| ESTABLISHMENT NAME | PENMED MARKETING SDN. BHD. |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GB6942221-72898 |
| BRAND NAME | SHENZHEN FITFAITH TECHNOLOGY CO., LTD. |
| MEDICAL DEVICE CATEGORY | MD 1100 - GENERAL ACTIVE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | Finger Pulse Oximeter Model: M100, M110, M120, M130, M150, M160, M170. Classification: Class IIa, Rule 10 ACCORDING TO ANNEX IX OF THE MDD 93/42/EEC. Parameters measured by the oximeter include: arterial oxygen (SpO2), pulse rate (PR), bargraph and plenthysmogram. The security classification of the M100 system software is class B, that is it won't cause serious damage. Before measuring those parameters, select a suitable site for the oximeter, for example the users index finger. Alternative sites recommended are the thumb, large toe or little finger. The material which contact with the body parts is silicone without any medical substance, tissue or blood products, and it is non sterile and latex free. Users contact materials have undergone extensive biocompatibility testing. The M100 series oximeter is operated and controlled by the buttons on the top. It adopts a 0.96 inch color OLED screen in displaying measurements and in supplementary status indication. |
| DEVICE INTENDED PURPOSE | This product is suitable for the hospital (including surgery, paediatrics, and clinical use), and community health care, etc. The product is not suitable for monitoring patient in ICU. |
| VALIDITY DATE OF REGISTRATION | 20/09/2021 - 19/09/2026 |