K091940 is an FDA 510(k) clearance for the MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION. This device is classified as a Stimulator, Electrical, Evoked Response (Class II - Special Controls, product code GWF).
Submitted by Tonica Elektronik A/S (Farum, DK). The FDA issued a Cleared decision on March 26, 2010, 269 days after receiving the submission on June 30, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K091940 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2009 |
| Decision Date | March 26, 2010 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWF - Stimulator, Electrical, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1870 |