The following data is part of a premarket notification filed by Magstim Company Ltd. with the FDA for Magstim Horizon 3.0 Tms Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 With Navigation.
| Device ID | K211389 |
| 510k Number | K211389 |
| Device Name: | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 With Navigation |
| Classification | Transcranial Magnetic Stimulator |
| Applicant | Magstim Company Ltd. Spring Gardens Whitland, GB Sa34 0hr |
| Contact | Tom Campbell |
| Correspondent | Tom Campbell Magstim Company Ltd. Spring Gardens Whitland, GB Sa34 0hr |
| Product Code | OBP |
| CFR Regulation Number | 882.5805 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-05 |
| Decision Date | 2021-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060229532800 | K211389 | 000 |
| 05060229532602 | K211389 | 000 |
| 05060229532619 | K211389 | 000 |
| 05060229532626 | K211389 | 000 |
| 05060229532633 | K211389 | 000 |
| 05060229532640 | K211389 | 000 |
| 05060229532657 | K211389 | 000 |
| 05060229532671 | K211389 | 000 |
| 05060229532695 | K211389 | 000 |
| 05060229532701 | K211389 | 000 |
| 05060229532732 | K211389 | 000 |
| 05060229532749 | K211389 | 000 |
| 05060229532718 | K211389 | 000 |