K931966 is an FDA 510(k) clearance for the DANTEC DISPOSABLE CONCENTRIC NEEDLE. This device is classified as a Electrode, Needle, Diagnostic Electromyograph (Class II - Special Controls, product code IKT).
Submitted by Dantec Medical, Inc. (Washington, US). The FDA issued a Cleared decision on March 30, 1994, 343 days after receiving the submission on April 21, 1993.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1385.
| 510(k) Number | K931966 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 1993 |
| Decision Date | March 30, 1994 |
| Days to Decision | 343 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | IKT — Electrode, Needle, Diagnostic Electromyograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1385 |