K931923 is an FDA 510(k) clearance for the DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE). This device is classified as a Stimulator, Electrical, Evoked Response (Class II - Special Controls, product code GWF).
Submitted by Dantec Medical, Inc. (Washington, US). The FDA issued a Cleared decision on November 9, 1993, 207 days after receiving the submission on April 16, 1993.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K931923 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 1993 |
| Decision Date | November 09, 1993 |
| Days to Decision | 207 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 |