510(k) K182768

Device

TMS-Cobot TS MV

Applicant

Axilum Robotics

510(k) number

K182768

Product code

QFF  

Decision

Substantially Equivalent (SESE)

Decision date

2019-02-17

Date received

2018-09-28

Regulation

882.5805

Classification name

Electromechanical Arm For A Transcranial Magnetic Stimulation System

Medical specialty

Neurology

Review panel

Neurology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No