MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Primary DI

M9831501000021

Basic UDI-DI Code

B-M9831501000021

Reference

OS-NeurOs, SEN-NeurOs

Device Types

None provided

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Mespere LifeSciences Inc

• SEN- NeurOs (S): VO200S NeurOs Cerebral Oximetry Sensor that detects signal, transmits and collects data, perform calculation and transmits from the sensor to the display monitor. An isolation device provides electrical isolation between the display monitor and the sensor. The VO200S is the modified version of the VO200 sensor but with a smaller sensor head to enhance usability. •Mespere OS-NeurOs: Mespere Operating system displays the measured cerebral oxygen saturation (StO2) in percentage (%) and it’s trending change at a refresh rate of approximately one (1) second. Screenshots of the patient’s StO2 and trend can be saved to a user specified folder. Mespere Operating System contains the Instructions for Use or QuickStart Guide, and Frequently Asked Questions document under the help folder • SA-NeurOs (S): VO200S NeurOs sensor adhesive is used to adhere the sensor to the patient’s forehead. The adhesive is single use and medical grade. For more information, please refer to Section 15: Biocompatibility.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).