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
Applicant Contact#
- Contact
- Romuald Ginhoux
- Address
- 8 Rue Schertz Strasbourg FR 67100 67100
FDA Registration Numbers#
- 3007147067
- 3030130442
- 3022310762
- 3014805507
Source Documents#
Other 510(k) Records For Product Code QFF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261471 | Zeta TMS Navigation System | Zeta Surgical, Inc. | 2026-07-09 |
Legacy Summary#
summary