The following data is part of a premarket notification filed by Magstim Company Us, Llc. with the FDA for Magstim 200-2.
Device ID | K060847 |
510k Number | K060847 |
Device Name: | MAGSTIM 200-2 |
Classification | Stimulator, Electrical, Evoked Response |
Applicant | MAGSTIM COMPANY US, LLC. 304 CAMBRIDGE RD SUITE 502 Woburn, MA 01801 |
Contact | Reza Jalinous |
Correspondent | Reza Jalinous MAGSTIM COMPANY US, LLC. 304 CAMBRIDGE RD SUITE 502 Woburn, MA 01801 |
Product Code | GWF |
CFR Regulation Number | 882.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-28 |
Decision Date | 2006-09-26 |
Summary: | summary |