The following data is part of a premarket notification filed by The Magstim Company Ltd. with the FDA for Magstim Double 70-2 Coil.
| Device ID | K130403 |
| 510k Number | K130403 |
| Device Name: | MAGSTIM DOUBLE 70-2 COIL |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | THE MAGSTIM COMPANY LTD. 101 MILK ST. Methuen, MA 01844 |
| Contact | J. P Ouellette |
| Correspondent | J. P Ouellette THE MAGSTIM COMPANY LTD. 101 MILK ST. Methuen, MA 01844 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-19 |
| Decision Date | 2013-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060229531506 | K130403 | 000 |