K895460 is an FDA 510(k) clearance for the CONCENTRIC ELECTRODE TYPE #13R01, 13R02. This device is classified as a Electrode, Needle, Diagnostic Electromyograph (Class II - Special Controls, product code IKT).
Submitted by Dantec Electronics, Inc. (Allendale, US). The FDA issued a Cleared decision on June 18, 1990, 285 days after receiving the submission on September 6, 1989.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.1385.
| 510(k) Number | K895460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1989 |
| Decision Date | June 18, 1990 |
| Days to Decision | 285 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | IKT — Electrode, Needle, Diagnostic Electromyograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.1385 |