The following data is part of a premarket notification filed by Magstim Company Ltd. with the FDA for Horizon Tms Therapy System With Navigation.
| Device ID | K183376 |
| 510k Number | K183376 |
| Device Name: | HORIZON TMS Therapy System 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 | 2018-12-06 |
| Decision Date | 2019-04-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B195NT150 | K183376 | 000 |
| B195NT149 | K183376 | 000 |
| B195NT115 | K183376 | 000 |
| B195NT103 | K183376 | 000 |
| B195NH134 | K183376 | 000 |
| B195ES600 | K183376 | 000 |
| B195EE410 | K183376 | 000 |
| B195666601 | K183376 | 000 |
| 05060229532541 | K183376 | 000 |