The following data is part of a premarket notification filed by Axilum Robotics with the FDA for Tms-cobot Ts Mv.
| Device ID | K182768 |
| 510k Number | K182768 |
| Device Name: | TMS-Cobot TS MV |
| Classification | Electromechanical Arm For A Transcranial Magnetic Stimulation System |
| Applicant | Axilum Robotics 8 Rue Schertz Strasbourg, FR 67100 |
| Contact | Romuald Ginhoux |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, PA 19103 |
| Product Code | QFF |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03701354630116 | K182768 | 000 |
| 03701354620261 | K182768 | 000 |
| 03701354620117 | K182768 | 000 |
| 03701354620285 | K182768 | 000 |
| 03701354600058 | K182768 | 000 |
| 03701354600034 | K182768 | 000 |