K071821 is an FDA 510(k) clearance for the COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65. 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 July 27, 2007, 24 days after receiving the submission on July 3, 2007.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1870.
| 510(k) Number | K071821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2007 |
| Decision Date | July 27, 2007 |
| Days to Decision | 24 days |
| Submission Type | Special |
| 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 |