The following data is part of a premarket notification filed by The Magstim Company Ltd. with the FDA for Magstim Rapid2, Magstim Super Rapid2, Models 3004-000, 3005-00.
| Device ID | K051864 |
| 510k Number | K051864 |
| Device Name: | MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | THE MAGSTIM COMPANY LTD. SPRING GARDENS Carmarthenshire, Whales, GB Sa34 Ohr |
| Contact | Anthony Thomas |
| Correspondent | Anthony Thomas THE MAGSTIM COMPANY LTD. SPRING GARDENS Carmarthenshire, Whales, GB Sa34 Ohr |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-08 |
| Decision Date | 2005-12-21 |
| Summary: | summary |