510(k) K182768
K182768 is an FDA 510(k) premarket notification submitted by Axilum Robotics for the device "TMS-Cobot TS MV". The FDA issued a decision of Substantially Equivalent on February 17, 2019. The device falls under product code QFF (Electromechanical Arm For A Transcranial Magnetic Stimulation System), a Class II device regulated under 21 CFR 882.5805.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2019
- Date Received
- September 28, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electromechanical Arm For A Transcranial Magnetic Stimulation System
- Device Class
- Class II
- Regulation Number
- 882.5805
- Review Panel
- NE
- Submission Type
To provide guidance for the positioning and orientation of a transcranial magnetic stimulation (TMS) system coil under the supervision of a tracking system.