K881915 is an FDA 510(k) clearance for the DANTEC MAGNETIC STIMULATOR. This device is classified as a Stimulator, Electrical, Evoked Response (Class II - Special Controls, product code GWF).
Submitted by Dantec Electronics, Inc. (Allendale, US). The FDA issued a Cleared decision on October 17, 1988, 161 days after receiving the submission on May 9, 1988.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K881915 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1988 |
| Decision Date | October 17, 1988 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GWF — Stimulator, Electrical, Evoked Response |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1870 |