The following data is part of a premarket notification filed by The Magstim Company Ltd. with the FDA for Magstim Double 70mm Air Film Coil, Model 3910-00.
| Device ID | K080499 |
| 510k Number | K080499 |
| Device Name: | MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | THE MAGSTIM COMPANY LTD. SPRING GARDENS, WHITLAND Dyfed, Wales, GB Sa34 0hr |
| Contact | Anwen Evans |
| Correspondent | Anwen Evans THE MAGSTIM COMPANY LTD. SPRING GARDENS, WHITLAND Dyfed, Wales, GB Sa34 0hr |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-25 |
| Decision Date | 2008-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060229530820 | K080499 | 000 |